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July 2015 Drug Information Update Table of Contents NEW GENERICS TO MARKET ........................................................................................................... 2 NEW DRUG ENTITIES....................................................................................................................... 4 NEW INDICATIONS (EXISTING DRUGS) ........................................................................................... 8 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ..................................................................... 9 STUDIES and RECENT TOPICS ........................................................................................................ 23 RECALLS ......................................................................................................................................... 30 CURRENT DRUG SHORTAGES ........................................................................................................ 49 NEW DRUGS COMING TO MARKET .............................................................................................. 97 Copyright© PerformRx, LLC 2015 All Rights Reserved 1 NEW GENERICS TO MARKET GENERIC DRUG NAME STRENGTH & DOSAGE FORM GENERIC MANUFACTURER BRAND NAME APPROVAL DATE HYDROCORTISONE/IODOQUINOL/A LOE 1.9 % - 1 %, CREAM PACK BOWYN LABS, LLC VYTONE 06/02/2015 NAFTIFINE HCL 1%, CREAM (G) RENAISSANCE PHA NAFTIN 06/02/2015 PNV73/IRON,CARB&GLU/FA/DSS/D HA 35 MG IRON - 1 MG - 50 MG - 300 MG, COMBO. PKG METHOD PHARMACE CITRANATAL ASSURE 06/04/2015 RISEDRONATE SODIUM 35 MG, TABLET TEVA USA, ACTAVIS PHARMA ACTONEL 06/02/2015 RISEDRONATE SODIUM 30 MG, TABLET TEVA USA, ACTAVIS PHARMA ACTONEL 06/02/2015 RISEDRONATE SODIUM 5 MG, TABLET TEVA USA, ACTAVIS PHARMA ACTONEL 06/02/2015 SILDENAFIL CITRATE 10 MG/12.5 ML, VIAL AUROMEDICS PHAR REVATIO 06/02/2015 PNV72/IRON,CARB&GLU/FA/DSS/D HA 90 MG IRON - 1 MG - 50 MG - 300 MG, COMBO. PKG METHOD PHARMACE CITRANATAL 90 DHA 06/09/2015 TRAMADOL HCL 100 MG, CPBP 25-75 TRIGEN LABORATO CONZIP 06/05/2015 TRAMADOL HCL 200 MG, CPBP 25-75 TRIGEN LABORATO CONZIP 06/05/2015 TRAMADOL HCL 300 MG, CPBP 17-83 TRIGEN LABORATO CONZIP 06/05/2015 DULOXETINE HCL 40 MG, CAPSULE DR LUPIN PHARMA IRENKA 06/08/2015 SALICYLIC ACID 28.50%, SOL-FILMER KMM PHARMACEUTI. ULTRASAL-ER 06/05/2015 HYDROXYZINE HCL 25 MG/Ml, VIAL AMER. REGENT HYDROXYZINE HCL 11/12/1987 HYDROXYZINE HCL 50 MG/Ml, VIAL ROERIG,J.B., EDWARDS PHARM., AMER. REGENT HYDROXYZINE HCL 03/03/1988, 03/11/1984, 11/12/1987 GLATIRAMER ACETATE 20 MG/ML, SYRINGE SANDOZ COPAXONE 06/19/2015 DEXMETHYLPHENIDATE HCL 20 MG, CPBP 50-50 TEVA USA, SANDOZ FOCALIN XR 06/22/2015, 6/23/2015 LINEZOLID 600 MG, TABLET TEVA USA ZYVOX 06/23/2015 HYPOCHLOROUS ACID/SODIUM CHLOR 0.01%, SPRAY OCULUS INNOVATI AVENOVA 06/22/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved 2 GENERIC DRUG NAME STRENGTH & DOSAGE FORM GENERIC MANUFACTURER BRAND NAME APPROVAL DATE FENOFIBRATE 120 MG, TABLET GLOBAL PHARM FENOGLIDE 06/19/2015 HYDROCODONE/ACETAMINOPHEN 10 mg-300 mg/15 mL, SOLUTION AKORN INC. LORTAB 06/23/2015 PYRIDOSTIGMINE BROMIDE 180 MG, TABLET ER ALVOGEN INC MESTINON 06/29/2015 ASPIRIN/DIPYRIDAMOLE 25 MG-200 MG, CPMP 12HR ROXANE LABS, TEVA USA AGGRENOX 06/30/2015, 07/01/2015 KETOCONAZOLE 2%, FOAM PERRIGO CO. EXTINA 08/29/2011 ALMOTRIPTAN MALATE 12.5 MG, TABLET TEVA USA, PATRIOT PHARMAC AXERT 07/07/2015 ALMOTRIPTAN MALATE 6.25 MG, TABLET TEVA USA, PATRIOT PHARMAC AXERT 07/07/2015 BEXAROTENE 75 MG, CAPSULE MYLAN TARGRETIN 07/09/2015 BIVALIRUDIN 250 MG, VIAL HOSPIRA, SANDOZ ANGIOMAX 07/30/2015, 07/07/2015 CAFFEINE/SODIUM BENZOATE 250 MG/Ml (125 MG/mL caffeine), VIAL AMER. REGENT CAFFEINE AND SODIUM BENZOATE 02/16/1994 FLUOXYMESTERONE 10 MG, TABLET UPSHER SMITH ANDROXY 04/29/1984 MEMANTINE HCL 10 MG, TABLET MYLAN, ACTAVIS PHARMA, NAMENDA 07/13/2015 MEMANTINE HCL 5 MG, TABLET MYLAN, ACTAVIS PHARMA, NAMENDA 07/13/2015 MEMANTINE HCL 5 mg (28)-10 mg (21), TAB DS PK ACTAVIS PHARMA NAMENDA 07/13/2015 BALSAM PERU/CASTOR OIL 87 MG-788 MG/GM, OINT PACK STRATUS PHARM VENELEX 07/16/2015 FENTANYL CITRATE-0.9 % NACL/PF 10 mcg/mL, SYRINGE PHARMEDIUM/OF FENTANYL CITRATE-0.9% NACL 07/23/2015 PRAMIPEXOLE DI-HCL 3 MG, TAB ER 24H PAR PHARM. MIRAPEX ER 07/21/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved 3 NEW DRUG ENTITIES DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NARCOTIC ANTITUSSIVE1ST GENERATION ANTIHISTAMINE SEROTONINNOREPINEPHRINE REUPTAKE-INHIB (SNRIS) ANTIPSYCHOTICS,ATYPICA L,DOPAMINE,& SEROTONIN ANTAG ANTIPSYCHOTICS,ATYPICA L,DOPAMINE,& SEROTONIN ANTAG ANTIPSYCHOTICS,ATYPICA L,DOPAMINE,& SEROTONIN ANTAG ANTIPSYCHOTICS,ATYPICA L,DOPAMINE,& SEROTONIN ANTAG TETRACYCLINES PROMETHAZINECODEINE PROMETHAZINE HCL/CODEINE 6.25-10/5 IRENKA DULOXETINE HCL 40 MG DORYX DOXYCYCLINE HYCLATE 50 MG NARCOTIC ANTITUSSIVE1ST GENERATION ANTIHISTAMINE BARBITURATES TUZISTRA XR CODEINE POLI/CHLORPHENIR POLIS 14.7-2.8/5 PHENOBARBITAL PHENOBARBITAL 20 MG/5 ML DILUENT PRODUCTS DILUENT-MERCK LIVE VIRUS VACC DILUENT #1,LIV VIRUS VAC(SWFI) - DILUENT PRODUCTS DILUENT FOR YFVAX DILUENT,YELLW FEV VAC,MDV,NACL 0.9% DILUENT PRODUCTS DILUENT FOR YFVAX DILUENT,YELLOW FEV VAC,SD,NACL 0.9% PRENATAL VITAMIN PREPARATIONS PEDIATRIC VITAMIN PREPARATIONS PEDIATRIC VITAMIN PREPARATIONS PKU TX AGENT-COFACTOR OF PHENYLALANINE HYDROXYLASE BETA-ADRENERGIC AND GLUCOCORTICOID TRISTART DHA PRENATAL NO.93/IRON/FA #9/DHA PEDI MULTIVIT #90 WFLUORIDE PEDI MULTIVIT #90 WFLUORIDE SAPROPTERIN DIHYDROCHLORIDE 31-1-200 MG FLUTICASONE/VILANTEROL 200-25 MCG NOTES 5 mL in 1 CUP NEW STRENGTH INVEGA TRINZA PALIPERIDONE PALMITATE 273 MG/.875 New Formulation INVEGA TRINZA PALIPERIDONE PALMITATE 410/1.315 New Formulation INVEGA TRINZA PALIPERIDONE PALMITATE 546 MG/1.75 New Formulation INVEGA TRINZA PALIPERIDONE PALMITATE 819/2.625 New Formulation POLY-VI-FLOR FS POLY-VI-FLOR FS KUVAN BREO ELLIPTA Copyright© PerformRx, LLC 2015 All Rights Reserved New Strength/Dosage Form New Combination 0.25 MG 0.5 MG 5 mL in 1 CUP Will not process until pricing is provided Will not process until pricing is provided Will not process until pricing is provided New Combination New Strength New Strength 500 MG New Strength New Strength 4 DESCRIPTION BRAND NAME GENERIC NAME PROTECTIVES BEAU RX TOPICAL ANTIINFLAMMATORY STEROIDAL ANTINEOPLASTICS ANTIBODY/ANTIBODYDRUG COMPLEXES TX FOR ATTENTION DEFICITHYPERACT(ADHD)/NARCO LEPSY ANTISEBORRHEIC AGENTS DERMACINRX SILAPAK DI-ME SILOX/DIMETHIC/HEXAMETH Y TRIAMCINOLONE ACET/DIMETHICONE UNITUXIN DINUTUXIMAB STRENGTH NOTES New Combination 0.1%-5% New Combination 3.5 MG/ML New Entity RITALIN LA METHYLPHENIDATE HCL 60 MG OVACE PLUS SULFACETAMIDE SODIUM 9.8% PLATELET AGGREGATION INHIBITORS TOPICAL SULFONAMIDES KENGREAL CANGRELOR TETRASODIUM 50 MG AVAR LS SULFACETAMIDE SODIUM/SULFUR 10 %-2 % TOPICAL SULFONAMIDES AVAR SULFACETAMIDE SODIUM/SULFUR 9.5 %-5 % INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES ANGIOTENSIN RECEPTNEPRILYSIN INHIBITOR COMB(ARNI) ANGIOTENSIN RECEPTNEPRILYSIN INHIBITOR COMB(ARNI) ANGIOTENSIN RECEPTNEPRILYSIN INHIBITOR COMB(ARNI) CYSTIC FIBROSIS-CFTR POTENTIATOR & CORRECTOR COMB. OXAZOLIDINONES FLUZONE QUAD 2015-2016 FLUZONE QUAD PEDI 2015-2016 FLUZONE QUAD 2015-2016 FLUZONE QUAD 2015-2016 FLUZONE 20152016 FLUZONE HIGHDOSE 2015-2016 ENTRESTO FLU VACCINE QS 2015-16 (6MOS+) FLU VACC QS 2015 (635MOS)/PF FLU VACC QS 201516(36MOS+)/PF FLU VACC QS 201516(36MOS+)/PF FLU VACCINE TS 2015-16(6 MOS+) FLU VACC TS 2015-16 (65YR+)/PF SACUBITRIL/VALSARTAN 60MCG/.5ML 30MCG/0.25 60MCG/.5ML 60MCG/.5ML 45MCG/.5ML 180MCG/0.5 New Strength/Dosage Form New Strength New Entity New Strength/Dosage Form New Strength/Dosage Form New Formulation New Formulation New Formulation New Formulation New Formulation New Formulation 24 MG-26MG New Combination ENTRESTO SACUBITRIL/VALSARTAN 49 MG-51MG New Combination ENTRESTO ORKAMBI SACUBITRIL/VALSARTAN LUMACAFTOR/IVACAFTOR 97MG103MG New Combination 200-125MG New Combination LINEZOLID-0.9% NACL LINEZOLID-0.9% SODIUM CHLORIDE Copyright© PerformRx, LLC 2015 All Rights Reserved 600MG/300 New Formulation 5 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES FLUVIRIN 20152016 FLUVIRIN 20152016 FLUCELVAX 20152016 FLUZONE INTRADERM QUAD 2015-16 FLUBLOK 20152016 FLULAVAL QUAD 2015-2016 PRESTALIA FLU VACCINE TS 20152016(4YR+) FLU VACCINE TS201516(4YR+)/PF FLU VACC TS 15-16 (18+)CELL/PF FLU VACC QS 2015 (1864YRS)/PF 45MCG/.5ML FLU VAC TV 2015(18 YR+)RCM/PF FLU VACCINE QS 201516(36MOS+) PERINDOPRIL ARG/AMLODIPINE BES 135MCG/0.5 INFLUENZA VIRUS VACCINES INFLUENZA VIRUS VACCINES ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED KERATOLYTICS PRESTALIA PRESTALIA REXULTI 45MCG/.5ML 45MCG/.5ML NOTES New Formulation New Formulation New Formulation 36MCG/.1ML New Formulation 60MCG/.5ML New Formulation New Formulation 14MG-10MG New Combination PERINDOPRIL ARG/AMLODIPINE BES 3.5-2.5 MG PERINDOPRIL ARG/AMLODIPINE BES 7 MG-5 MG BREXPIPRAZOLE 0.25 MG New Combination New Combination New Entity REXULTI BREXPIPRAZOLE 0.5 MG New Entity REXULTI BREXPIPRAZOLE 1 MG New Entity REXULTI BREXPIPRAZOLE 2 MG New Entity REXULTI BREXPIPRAZOLE 3 MG New Entity REXULTI BREXPIPRAZOLE 4 MG New Entity CARB-O-PHILIC UREA 40 % TOPICAL ANTIINFLAMMATORY, NSAIDS PEDIATRIC VITAMIN PREPARATIONS DERMACINRX LEXITRAL TEXAVITE LQ DICLOFENAC/CAPSICUM 1.5-0.025% 7-.25MG/ML EMOLLIENTS ALEVICYN ANTIPRURITIC SG PED MULTIVIT#108/IRON/FLUORI DE EMOLLIENT COMBINATION NO.60 Copyright© PerformRx, LLC 2015 All Rights Reserved New Strength and Dosage Form New Combination New Combination - New Combination 6 DESCRIPTION BRAND NAME GENERIC NAME STRENGTH ACNE AGENTS,TOPICAL EPIDUO FORTE 0.3 %-2.5% WOUND HEALING AGENTS, LOCAL DERMACINRX SURGICAL PHARMAPAK SILMANIX ADAPALENE/BENZOYL PEROXIDE MUPIROCIN/CL-HEX GL/DMC/SILICO IRRITANTS/COUNTERIRRITANTS CAPSAICIN/MENTHOL/HISTA MINE Copyright© PerformRx, LLC 2015 All Rights Reserved NOTES New Strength 2 %-4 %-5% New Combination 0.0375%-3% New Combination 7 NEW INDICATIONS (EXISTING DRUGS) DRUG NEW INDICATION DATE OF APPROVAL LINKS LENVIMA® ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA RELAPSED MULTIPLE MYELOMA UPPER LIMB SPASTICITY IN ADULTS June 29, 2015 Lenvima® [package insert]. Eisai Co., Ltd June 2015 July 24, 2015 Kyprolis® [package insert]. Amgen July 2015 Dysport® [package insert]. Ipsen July 2015 KYPROLIS® DYSPORT® Copyright© PerformRx, LLC 2015 All Rights Reserved July 16, 2015 8 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication Permanent Skin Color Changes [Posted 06/24/2015] ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for photos of chemical leukoderma. Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress. BACKGROUND: The Daytrana patch treats ADHD by working to increase attention and decrease restlessness in children and adolescents who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. RECOMMENDATION: Patients or their caregivers should watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to their health care professionals. Patients should not stop using the Daytrana patch without first talking to their health care professionals. FDA recommends that health care professionals consider alternative treatments for patients who experience these skin color changes. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm452595.htm Copyright© PerformRx, LLC 2015 All Rights Reserved 9 FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation [Posted 07/01/2015] ISSUE: FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet. The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of patient tubings or when the CO2 absorber is replaced. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately. The firm has received 10 foreign reports this device has malfunctioned; no injuries or deathshave been reported. BACKGROUND: The Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with no or limited ability to breathe. The system is used in hospitals, for use in a range of patients from neonatal to adult. RECOMMENDATION: A Maquet Service representative will contact consignees to arrange replacement of the FLOW-i Anesthesia System patient cassette locking device. For questions regarding this field action, please contact a Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm453524.htm Copyright© PerformRx, LLC 2015 All Rights Reserved 10 Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality [Posted 07/01/2015] ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. Unapproved prescription otic drug products containing the following ingredients are covered by this action: •benzocaine •benzocaine and antipyrine •benzocaine, antipyrine, and zinc acetate •benzocaine, chloroxylenol, and hydrocortisone •chloroxylenol and pramoxine •chloroxylenol, pramoxine, and hydrocortisone. BACKGROUND: FDA informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter. RECOMMENDATION: Consumers who believe they are using unapproved prescription ear drops should contact their health care provider to discuss alternatives. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) Copyright© PerformRx, LLC 2015 All Rights Reserved 11 ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm453430.htm Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects [Posted 07/01/2015] ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids. In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete. BACKGROUND: Codeine is a specific type of narcotic medicine called an opioid that is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines. RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should always read the product label to find out if a medicine contains codeine and talk with their child’s health care professional or a pharmacist if they have any questions or concerns. Health care professionals should continue to follow the recommendations in the drug labels and use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Copyright© PerformRx, LLC 2015 All Rights Reserved 12 Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm453379.htm Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke [Posted 07/09/2015] ISSUE: FDA is strengthening an existing label warning that non-aspirin nonsteroidal antiinflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products. Prescription NSAID labels will be revised to reflect the following information: The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater at higher doses. It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID. NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline. Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack. There is an increased risk of heart failure with NSAID use. Copyright© PerformRx, LLC 2015 All Rights Reserved 13 BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014. RECOMMENDATION: Patients and health care professionals should remain alert for heartrelated side effects the entire time that NSAIDs are being taken. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm454141.htm Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration [Posted 07/14/2015] ISSUE: In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10% w/v, packaged in 10 mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. FDA has recently become aware that some units of this drug may still be on the market. Please check your inventory and crash boxes, quarantine and discontinue distribution and use of affected lots. BACKGROUND: Calcium Chloride Intravenous Infusion 10% w/v is used as part of the resuscitation procedure following a cardiac arrest and for the treatment of low calcium levels. It is also used for arrhythmias associated with hypocalcaemia, hyperkalaemia or hypomagnesaemia. Because of the use of Calcium Chloride Intravenous Infusion prefilled syringes in emergency situations and its use as a lifesaving drug, difficulty in the administration Copyright© PerformRx, LLC 2015 All Rights Reserved 14 of the drug could create a potential risk by prohibiting or delaying the administration of the medication. RECOMMENDATION: Immediately examine your inventory and crash boxes, quarantine and discontinue distribution and use of these lots. If you have the affected product, please contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product. In addition, if you have further distributed the affected product, please identify your customers and notify them at once of this market withdrawal. The customer should be instructed to contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product. Additionally, Stericyle will notify your retail level customers that received the affected lots. Provide a list of customers via Microsoft Excel file to [email protected] within 10 business days. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm454836.htm Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns [Posted 07/16/2015] ISSUE: FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information. BACKGROUND: FDA identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide, the active ingredient in Proglycem, since the drug was approved in 1973. RECOMMENDATION: Proglycem is usually given in the hospital, and health care professionals should closely monitor babies receiving it, especially those with risk factors for pulmonary Copyright© PerformRx, LLC 2015 All Rights Reserved 15 hypertension such as meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, and congenital heart disease. Stop Proglycem treatment if pulmonary hypertension is identified. Parents and caregivers of any child receiving Proglycem should watch for signs of difficulty breathing such as flaring nostrils, grunting, unusual movement of their child’s chest, rapid breathing, difficulty feeding, or a bluish color of the lips or skin. Immediately alert your child’s health care professionals if you see any of these signs, and talk to them if you have any questions or concerns about Proglycem. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm455125.htm 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter [Posted 07/20/2015] ISSUE: Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. This recall affects Lot Numbers P319921 and P327635. BACKGROUND: The lots being recalled were distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015. Copyright© PerformRx, LLC 2015 All Rights Reserved 16 RECOMMENDATION: Baxter is directing customers not to use product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement. Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm455421.htm Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance [Posted 07/24/2015] ISSUE: Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. BACKGROUND: The recalled products were made from 7/21/2014 through 7/21/2015, and dispensed to patients or distributed to physicians for further administering to patients in the states of Arizona, Idaho, Florida, Oregon, Texas, and Washington. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product. The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy or to products compounded after July 21, 2015. Copyright© PerformRx, LLC 2015 All Rights Reserved 17 RECOMMENDATION: The pharmacy has begun notifying its patients by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products. To return product or request assistance related to this recall, users should call 509-764-2314, Monday through Friday, from 8:30 a.m. to 12:30 p.m. and 1 to 5:30 p.m. PDT.; Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking these drug products. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm455931.htm Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use [Posted 07/27/2015] ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadoliniumbased contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects. FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. FDA is working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, FDA is not requiring manufacturers to make changes to the labels of GBCA products. BACKGROUND: After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function. Available information does not identify any adverse health effects. Copyright© PerformRx, LLC 2015 All Rights Reserved 18 RECOMMENDATION: To reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols. Patients, parents, and caregivers should talk to their health care professionals if they have any questions about the use of GBCAs with MRIs. This issue affects only GBCAs; it does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm456012.htm Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter [Posted 07/27/2015] ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall. See the press release for product lot numbers affected by this recall. BACKGROUND: Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages. RECOMMENDATION: Teva is arranging for impacted product to be returned to Inmar. Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility. Customers who Copyright© PerformRx, LLC 2015 All Rights Reserved 19 have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm456114.htm Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion [Posted 07/30/2015] ISSUE: FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue. BACKGROUND: Brintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder (MDD) in adults. It is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Brilinta (ticagrelor) is an antiplatelet, anti-blood clotting medication used to lower the risk of having another heart attack, or dying from a heart problem after a heart attack or severe chest pain. RECOMMENDATION: Health care professionals can reduce the risk of name confusion by including the generic (established) name of the medication, in addition to the brand name, and the indication for use when prescribing these medications. Patients should check their prescriptions to ensure that the correct medication was dispensed. See the FDA Drug Safety Communication for more detailed recommendations Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Copyright© PerformRx, LLC 2015 All Rights Reserved 20 Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm456569.htm 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall Potential For Leaking Containers, Particulate Matter and Missing Port [Posted 07/31/2015] ISSUE: Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. BACKGROUND: The lot being recalled was distributed to customers and distributors nationwide between January 22, 2015 and February 12, 2015. This recall affects the following lot Number: C964601, NDC: 0338-0049-03; Expiration Date: 04/30/2016 RECOMMENDATION: Customers were notified via letter that they should not use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 SOURCE: U.S. Food and Drug Administration (FDA) Copyright© PerformRx, LLC 2015 All Rights Reserved 21 ARTICLE LINK: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProdu cts/ucm456793.htm Copyright© PerformRx, LLC 2015 All Rights Reserved 22 STUDIES and RECENT TOPICS Biohackers Aim To Make Homebrew Insulin, But Don't Try It Yet July 15, 2015 Might people with diabetes someday be able to brew their own insulin for free at home, just as with beer? The answer may be yes, but whether it's a good idea is another question. Article link: http://www.npr.org/sections/health-shots/2015/07/15/422935288/biohackers-aim-to-makehomebrew-insulin-but-dont-try-it-yet Antidepressants And Painkillers Together May Raise The Risk Of Brain Bleeds July 15, 2015 A new study in the journal The BMJ finds that the risk of intracranial hemorrhage – bleeding that occurs in or around the brain – is increased when one combines antidepressants with nonsteroidal anti-inflammatory drugs (NSAIDS) like ibuprofen or naproxen. Since depression and chronic pain often go hand-in-hand, and millions of people may take the two meds together, the study results are particularly relevant. It’s important to note, however, that this study looked only at prescription NSAIDs, so doses may have been higher than what one might take with an over-the-counter versions. Still, the results raise questions about whether it’s advisable to combine the two drugs over the long term, or at all. Article link: http://www.forbes.com/sites/alicegwalton/2015/07/15/antidepressants-and-painkillerstogether-may-raise-the-risk-of-brain-bleeds/ High blood pressure danger equal for slim and obese alike July 16, 2015 Though previous research has suggested high blood pressure may be more dangerous for thinner people, a new study finds the cardiovascular disease risks are similar – and high - for the lean, overweight and the obese. “Some studies done in the past 30 years suggested that for the adverse outcomes associated with hypertension – such as heart attacks and stroke – lean or normal weight people with hypertension had worse outcomes than overweight or obese people with hypertension,” said lead author Laura A. Colangelo of the Feinberg School of Medicine at Northwestern University in Chicago. Article link: Copyright© PerformRx, LLC 2015 All Rights Reserved 23 http://www.reuters.com/article/2015/07/16/us-health-hypertension-weightidUSKCN0PQ1QC20150716 American Health Packaging pulls thousands of Wockhardt-made products from the market July 16, 2015 Company initiates 13 recalls of 6 products made by Indian drugmaker India's Wockhardt recently disclosed that the FDA was not happy that it had continued to sell in the U.S. products that it had manufactured at two plants before the agency banned them. As a result, the Indian drugmaker said it was going to have to recall anything left in the U.S. made at those facilities. That burden has fallen in part to American Health Packaging, a subsidiary of AmerisourceBergen, which has issued more than a dozen recalls of 6 products in different doses. Article link: http://www.fiercepharmamanufacturing.com/story/american-health-packaging-pullsthousands-wockhardt-made-products-market/2015-07-16 Biogen Reports Another Tecfidera PML Case July 16, 2015 There's been a second case of progressive multifocal leukoencephalopathy (PML) with dimethyl fumarate (Tecfidera) for multiple sclerosis, a Biogen spokesperson confirmed. The company said it reported the case -- which wasn't fatal -- to regulators including the FDA but would not specify where the case occurred. Article link: http://www.medpagetoday.com/Neurology/MultipleSclerosis/52622 Serious Lung Problem Seen in Babies Receiving Proglycem July 16, 2015 The FDA has identified 11 cases of pulmonary hypertension in infants and newborns treated with diazoxide (Proglycem). In all reported cases, the serious lung condition resolved or improved after the low blood sugar treatment was stopped.The FDA is investigating this issue to determine whether changes to Proglycem’s prescribing information are warranted. Article link: http://www.pharmacytimes.com/product-news/serious-lung-problem-seen-in-babiesreceiving-proglycem Copyright© PerformRx, LLC 2015 All Rights Reserved 24 Vitamin B12 Supplements May Not Help Some Seniors July 16, 2015 Vitamin B12 supplements are known to benefit seniors with severe B12 deficiency, but they may not help those who are just moderately deficient, a new study suggests. "Many people may be taking vitamin B12 supplements on a regular basis, and it has been thought they would enhance function in older people," said study author Dr. Alan Dangour, of the London School of Hygiene & Tropical Medicine. "Our study found no evidence of benefit for nervous system or cognitive function from 12 months of supplementation among older people with moderate vitamin B12 deficiency." Article link: http://consumer.healthday.com/senior-citizen-information-31/misc-aging-news-10/benefitsof-b12-supplements-not-seen-in-seniors-with-moderate-vitamin-deficiency-701014.html Aspirin Use Common Among Americans With Heart Trouble July 16, 2015 About seven in 10 Americans who've had heart disease or a stroke regularly take aspirin, U.S. health officials report. Low-dose aspirin is promoted as an inexpensive, effective way to prevent cardiovascular disease. Researchers from the U.S. Centers for Disease Control and Prevention wanted to know who takes it regularly (daily or every other day) and why. Article link: http://consumer.healthday.com/general-health-information-16/aspirin-news-46/aspirin-usecommon-for-americans-with-heart-history-701424.html Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers July 16, 2015 In a bid to push back against payers, Gilead Sciences is limiting enrollment to its patient assistance program for hepatitis C drugs, which helps people obtain the Sovaldi and Harvoni treatments when they lack sufficient insurance coverage or the financial wherewithal to get the medicines otherwise. Article link: http://blogs.wsj.com/pharmalot/2015/07/16/gilead-limits-enrollment-in-its-hep-c-patientprogram-to-pressure-insurers/ Copyright© PerformRx, LLC 2015 All Rights Reserved 25 FDA: More basic science research needed to accelerate cures July 17, 2015 Drug discovery is moving slowly for many diseases because of a “lack of understanding of the biology of disease,” a top Food and Drug Administration official recently wrote. Robert Califf, a deputy commissioner at the Food and Drug Administration, calls out the “paucity of reliable biomarkers in some diseases” in a recent blog post – citing it as a sign that a lot of disease research isn’t progressing as it should. Article link: http://medcitynews.com/2015/07/fda-more-basic-science-research-needed-to-acceleratecures Psoriasis Drug May Help Preserve Pancreas Cells in Type 1 Diabetes July 21, 2015 Taking two 12-week courses of alefacept -- a drug already approved to treat the skin condition psoriasis -- may help people with newly diagnosed type 1 diabetes preserve some function in the beta cells in the pancreas, a new study suggests. Article link: http://consumer.healthday.com/clinical-trials-information-35/clinical-trials-news-136/psoriasisdrug-helps-preserve-pancreas-cells-in-people-with-new-onset-type-1-diabetes-701510.html FDA Clears 2 New Propeller Health Devices That Track Respiratory Meds July 22, 2015 Propeller Health has received FDA clearance to sell two new devices to help chronic respiratory disease patients track their medication usage and better follow their recommended treatment regimens. Founded in 2010, the Madison, WI-based company makes data-collecting devices that snap on to medication inhalers used by asthma and chronic obstructive pulmonary disease (COPD) patients. The devices can note the time and location for each use, information that is stored and wirelessly transmitted to a user’s smartphone or a Qualcomm base station plugged into the wall at home. Propeller says its system—which combines sensors, mobile apps, analytics, and individualized feedback for patients and their caregivers—can help lower healthcare costs associated with asthma and COPD by helping patients and doctors better understand the diseases, predict attacks, and reduce hospitalizations. Article link: http://www.xconomy.com/wisconsin/2015/07/22/fda-clears-2-new-propeller-health-devicesthat-track-respiratory-meds/ Copyright© PerformRx, LLC 2015 All Rights Reserved 26 High Soda Intake May Boost Diabetes Risk, Even Without Obesity July 22, 2015 Whether you are slim or obese, if you drink lots of sugary soda or other sweetened drinks you are more likely to develop type 2 diabetes, a new analysis reveals. Until now, health experts have thought that sugary drinks and type 2 diabetes were linked because sugar promotes weight gain, and body fat contributes to insulin resistance, which precedes diabetes. Article link: http://www.nlm.nih.gov/medlineplus/news/fullstory_153691.html Generic Drug Duo More Effective Against Breast Cancer Than Tamoxifen July 23, 2015 Two inexpensive, generic drugs can reduce breast cancer deaths in postmenopausal women better than drugs now in wide use, researchers from two related studies concluded. Drugs called aromatase inhibitors help stop hormones including estrogen from spurring cancer growth. These drugs are more effective than widely used tamoxifen in reducing breast cancer death, according to the research. Article link: http://www.healthline.com/health-news/generic-drug-duo-more-effective-against-breastcancer-than-tamoxifen-072315 One big myth about medicine: We know how drugs work July 23, 2015 Here’s how we think we discover powerful new medicines: Scientists dig deep into biology and zero in on a molecular Achilles’ heel that could disable a devastating disease, be it cancer or an infection. They concoct experimental drugs that hit the target. Then they conduct trials to find one that is safe and effective in people. Article link: http://www.washingtonpost.com/news/wonkblog/wp/2015/07/23/one-big-myth-aboutmedicine-we-know-how-drugs-work/ Younger Adults With Alzheimer's Are Key To Drug Search July 23, 2015 The face of Alzheimer's isn't always old. Sometimes it belongs to someone like Giedre Copyright© PerformRx, LLC 2015 All Rights Reserved 27 Cohen, who is 37, yet struggles to remember her own name. Until about a year ago, Giedre was a "young, healthy, beautiful" woman just starting her life, says her husband, Tal Cohen, a real estate developer in Los Angeles. Now, he says, "her mind is slowly wasting away." Article link: http://www.npr.org/sections/health-shots/2015/07/23/425320514/younger-adults-withalzheimer-s-are-key-to-drug-search NSAIDS may increase kidney risks with high blood pressure July 23, 2015 People with high blood pressure who regularly take common painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs) may increase their risk of developing chronic kidney disease, a study from Taiwan suggests. While some previous research has linked NSAIDs to impaired kidney function, the results have been mixed and often overlooked the effects on people with high blood pressure, or hypertension, which itself carries an elevated risk for kidney damage. Article link: http://www.reuters.com/article/2015/07/23/us-health-hypertension-nsaids-kidneyidUSKCN0PX2OE20150723 FDA Examines Whether MRI Drugs Accumulate in Brain Tissue July 27, 2015 The Food and Drug Administration announced today it is investigating the risk of brain deposits for patients who are given repeated MRIs using imaging drugs that contain a heavy metal. The FDA did not announce any label changes for the nine medicines that contain the metal, gadolinium, saying there was a “need for additional information.” However, “to reduce the potential for gadolinium accumulation,” the safety announcement asked health care professionals to “consider limiting” their use and to reexamine “the necessity of repetitive” MRIs involving these drugs. Article link: http://www.propublica.org/article/fda-examines-whether-mri-drugs-accumulate-in-braintissue Serious Risks About Existing Drugs Aren’t Given to Trial Participants July 29, 2015 There are many reasons drugs already on the market continue to be studied, such as exploring new uses or conducting follow-up trials required by the FDA. And about 35% of the medicines Copyright© PerformRx, LLC 2015 All Rights Reserved 28 have boxed warnings on their prescribing labels, which contain the most serious type of risk information. But new research finds some serious risks are not disclosed on consent forms given to trial participants. Article link: http://blogs.wsj.com/pharmalot/2015/07/29/serious-risks-about-existing-drugs-arent-given-totrial-participants/ AMA, other groups take on patient drug abuse July 29, 2015 Several of the country's largest physician organizations are collaborating to address the recent rise in drug overdoses deaths that are due, in part, to the increased use of prescription opioid painkillers. A total of 27 physician groups led by the American Medical Association are urging physicians to register in prescription drug monitoring programs as a way to identify patients who may be at risk of abusing opioid drugs. Article link: http://www.modernhealthcare.com/article/20150729/NEWS/150729829/ama-other-groupstake-on-patient-drug-abuse Copyright© PerformRx, LLC 2015 All Rights Reserved 29 RECALLS* Product type Product description Code info. Class Reason for recall Recalling firm Class I Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramin e and phenolphthalein based on FDA sampling and analysis. Bethel Nutritional Consulting, Inc Class I Presence of Particulate Matter: Baxter Products recalled due Healthcare to presence of Corp. particulate matter (metal) CLASS I Drugs Drugs SLIM-K, 30 Capsules, barcode 160126417509 Lot # 140430; Exp.12/17 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags Lot #: C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016 Drugs 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags Lot #: C963413 and C963413A, Exp 7/31/2016 Class I Drugs 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags Lot #: C965558 and C963520, Exp 7/31/2016 Class I Drugs Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags Lot #: C964619, C964056 and C964163, Exp 7/31/2016 Drugs Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Lot #s: 31317858B, Exp 11/2015; Copyright© PerformRx, LLC 2015 All Rights Reserved Class I Class I Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Presence of Particulate Matter: Black particulate Baxter Healthcare Corp Baxter Healthcare Corp Baxter Healthcare Corp Teva Pharmaceutical s USA 30 Product type Drugs Product description Code info. Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016 Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only Lot #: 38-515DK, Expiry: 1 FEB 2016 Class Reason for recall Recalling firm matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Class I Presence of Particulate Matter: Presence of freefloating and embedded iron oxide particles Hospira Inc. CLASS II Drugs Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only Lot #: 6109469, 6109470, Exp 10/2016 Class II Drugs 0.9% Sodium Chloride Injection USP, 50 mL ADDVantage Unit, Rx only Lot #: 49-084JT; 49-119-JT Class II Drugs Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only Lot #: 5267605, Exp 08/2015 Class II Drugs Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only Lot #: 5267504, Exp 07/2015 Class II Drugs KETOROLAC Tromethamine Inj., USP, 31077DK, 31078DK, Class II Copyright© PerformRx, LLC 2015 All Rights Reserved Failed impurities/degradati on specifications; two lots are out-ofspecification for impurities and color Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Failed Impurities/Degradati on Specifications: failed specification for unknown impurity at the 24 month stability testing. Failed Impurities/Degradati on Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. Crystallization; identified as calcium Fresenius Kabi USA, LLC Hospira Inc. Kremers Urban Pharmaceutical s, Inc Kremers Urban Pharmaceutical s, Inc. Hospira Inc. 31 Product type Product description 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials Code info. 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016 ; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 Copyright© PerformRx, LLC 2015 All Rights Reserved Class Reason for recall Recalling firm salt of Ketorolac 32 Product type Product description Drugs KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, Drugs Losartan potassium tablets USP, 25 mg, 90count bottle, Rx only Code info. AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015 Lot #: KP4726, Exp date 9/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved Class Reason for recall Recalling firm Class II Crystallization; identified as calcium salt of Ketorolac Hospira Inc. Class II Failed Content Uniformity Specifications: The Apotex Inc 33 Product type Product description Code info. Class Drugs Losartan potassium tablets USP, 100 mg, 90count bottle, Rx only Lot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015 Class II Drugs Losartan potassium tablets USP, 50 mg, 90count bottle, Rx only Lot #: KN1449, Exp 06/2015 Class II Drugs Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only Lot #: KP4529, Exp 10/2015 Class II Drugs Drugs Drugs Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-49811); 10 blister packs per carton (NDC 68084-49801); Rx only Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-50511); 10 blister packs per carton (NDC 68084-50501); Rx only Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-50611); 10 blister packs per carton (NDC 68084-506- Lot #: 131924, Exp 07/31/2015 Lot#: 131954, 131955, Exp 08/31/2015 Lot#: 131953, Exp 07/31/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved Reason for recall product may not meet the limit for blend uniformity specification. Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Recalling firm Apotex Inc Apotex Inc Apotex Inc Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging 34 Product type Product description Code info. Class Reason for recall Recalling firm Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging 01); Rx only Drugs Drugs Drugs Azithromycin tablets, USP 500mg, packaged in 10count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only Azithromycin tablets, USP 600mg, packaged in 10count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only Azithromycin tablets, USP 250mg, packaged in 10count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only Drugs Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only Drugs Famotidine tablets, USP 20mg, packaged in 10count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only Lot#: 134419A, Exp 12/31/2015; Lot#: 193441B, Exp 02/29/2016; Lot#: 133684B, Exp 09/30/2015. Lot#: 134420, 142540, Exp 7/31/2015 Lot#: 134392, Exp 06/30/2015 Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015. Lot#: 132146, Exp 06/30/2015; Lot#: 132147, 132963, Exp 08/31/2015; Lot#: 132964, Exp 10/31/2015; Lot#: 134319, Exp Copyright© PerformRx, LLC 2015 All Rights Reserved 35 Product type Product description Code info. Class Reason for recall Recalling firm Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging Class II Failed Dissolution Specifications: low Mylan Pharmaceutical 12/31/2015; Lot#: 134320, Exp 01/31/2016. Drugs Drugs Drugs Drugs Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-06011); 10 blister packs per carton (NDC 68084-06001); Rx only Lisinopril tablets, USP 10mg packaged in 10count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only Lisinopril tablets, USP 20mg packaged in 10count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only Lisinopril tablets, USP 40mg packaged in 10count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only Drugs Zonisamide capsules, USP 100mg packaged in 10count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only Drugs Capecitabine Tablets, USP, 500 mg, 120-count bottle, Lot#: 131928, Exp 09/30/2015 Lot#: 131933, Exp 07/31/2015 Lot#: 131934, Exp 09/30/2015 Lot#: 131935, Exp 08/31/2015 Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016. Lot #: 3053562, Exp 02/16 Copyright© PerformRx, LLC 2015 All Rights Reserved 36 Product type Product description Code info. Class Rx only Drugs Drugs Drugs Drugs TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. Ped, Multi Vitamin, Rx Only TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and Copyright© PerformRx, LLC 2015 All Rights Reserved Reason for recall Recalling firm out-of-specification (OOS) results for dissolution were obtained at the ninemonth stability point. s Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc 37 Product type Drugs Drugs Drugs Drugs Product description for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx Only TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water Code info. Class Reason for recall Recalling firm Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc Class II Lack of Assurance of Sterility: Sterility of product is not assured. May 27, 2015 All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and May 27, 2015 All product compounded between May 14, 2015 and Copyright© PerformRx, LLC 2015 All Rights Reserved Lincare, Inc 38 Product type Drugs Drugs Drugs Drugs Product description for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol Code info. Class Reason for recall Recalling firm May 27, 2015 Lincare, Inc All product compounded between May 14, 2015 and May 27, 2015 Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc All product compounded between May 14, 2015 and May 27, 2015 Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc All product compounded between May 14, 2015 and May 27, 2015 Class II Lack of Assurance of Sterility: Sterility of product is not assured. All product compounded between May Class II Lack of Assurance of Sterility: Sterility of product is not Copyright© PerformRx, LLC 2015 All Rights Reserved Lincare, Inc 39 Product type Drugs Drugs Drugs Drugs Drugs Drugs Drugs Product description 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Code info. Class 14, 2015 and May 27, 2015 Reason for recall Recalling firm assured. Lincare, Inc All product compounded between May 14, 2015 and May 27, 2015 Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lincare, Inc All product compounded between May 14, 2015 and May 27, 2015 Compounded on 05/29/15, Discard After: 06/12/15 Compounded on 05/29/15, Discard After: 06/12/15 Compounded on 05/27/15, Discard After: 06/10/15 Compounded on 05/29/15, Discard After: 06/08/15 Compounded on 05/29/15, Copyright© PerformRx, LLC 2015 All Rights Reserved Class II Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lack of Assurance of Sterility: Sterility of product is not assured. Class II Class II Class II Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc 40 Product type Product description Bag, Rx Only Drugs VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only Drugs Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only Drugs CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only Drugs Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only Drugs Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only Drugs FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only Drugs Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only Drugs Drugs HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, Rx Only Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only Drugs Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only Drugs VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Code info. Discard After: 06/12/15 Compounded on 05/27/15, Discard After: 06/10/15 Compounded on 05/29/15, Discard After: 06/10/15 Compounded on 05/27/15; Discard After: 06/10/15 Compounded on 05/27/15, Discard After: 06/10/15 Compounded on 05/28/15, Discard After: 06/11/15 Compounded on 05/26/15, Discard After: 06/09/15 Compounded on 05/29/15, Discard After: 06/12/15 Compounded on 05/27/15, Discard After: 06/24/15 Compounded on 05/29/15, Discard After: 06/12/15 Compounded on 05/28/15, Discard After: 06/11/15 Compounded on 05/27/2015, Discard After: Copyright© PerformRx, LLC 2015 All Rights Reserved Class Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Reason for recall product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not Recalling firm Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc 41 Product type Product description Code info. Rx Only Drugs Drugs Drugs Drugs Drugs Drugs Drugs Drugs Drugs Drugs Drugs 06/06/2015 Compounded VANC 50MCG/ML-HEP on 05/27/2015, 100U/ML in 2ML, Packed Discard After: in 2 mL Units, Rx Only 06/11/2015 DEFEROXAMINE Compounded MESYLATE 3gm / NS on 05/28/2015, 240mL Accuflo, Packaged Discard After: in 240 mL Bags, Rx Only 06/11/2015 Compounded CEFEPIME 1gm / NS 50mL on 05/28/2015, AccuFlo, Packaged in 50 Discard After: mL Bags, Rx Only 06/11/2015 CIPROFLOXACIN 400MG / Compounded D5W 200ML ACCUFLO, on 05/28/2015, Packaged in 3 200 mL Discard After: Bags, Rx Only 06/11/2015 Vancomycin HCl / Heparin, Compounded Vancomycin 50mcg/ml / on 05/27/15, HEPARIN 100u/ml, Qty: 8, Discard After: Rx Only 06/10/15 Fentanyl Citrate, Compounded FENTANYL 25,000 MCG / on 05/29/15, 500 ML, Qty: 1 500 mL Discard After: Bag, Rx Only 06/26/15 Vancomycin, Compounded VANCOMYCIN 750mg / NS on 05/28/15, 100mL AccuFlo, Qty: 7 100 Discard After: mL Bags, Rx Only 06/11/15 Ceftriaxone Sodium, Compounded Ceftriaxone 2gm / NS on 05/29/15, 50mL, Qty: 12 50 mL Bags, Discard After: Rx Only 06/12/15 Diphenhydramine HCl, Compounded Diphenhydramine 25mg / on 05/27/15, NS 10 ml syringe, Qty: 2 Discard After: 10 mL syringes, Rx Only 06/10/15 Vancomycin HCl, Compounded Vancomycin 1500mg / on 05/10/15, D5W 265mL, Qty: 2 265 Discard After: mL Bags, Rx Only 06/10/15 Vancomycin HCl/Heparin, Compounded Vancomycin 50mcg/mL / on 05/27/15, Heparin 100u/mL, Qty: 3, Discard After: Rx Only 06/10/15 Class Copyright© PerformRx, LLC 2015 All Rights Reserved Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Reason for recall assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Recalling firm Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc 42 Product type Product description Drugs Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only Drugs Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only Drugs GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only Drugs Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only Drugs Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only Drugs Drugs Drugs Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only Drugs Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only Drugs HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only Drugs Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only Drugs Ganciclovir Sodium, Code info. Compounded on 05/27/15, Discard After: 06/10/15 Compounded on 05/29/2015, Discard After: 06/12/2015 Compounded on 05/27/2015, Discard After: 06/24/2015 Compounded on 05/29/2015, Discard After: 06/12/2015 Compounded on 05/27/2015, Discard After: 06/10/2015 Compounded on 05/28/15, Discard After: 06/11/15 Compounded on 05/29/15, Discard After: 06/12/15 Compounded on 05/30/15, Discard After: 06/13/15 Compounded on 05/28/15, Discard After: 06/11/15 Compounded on 05/29/15, Discard After: 06/26/15 Compounded on 05/29/15, Discard After: 06/12/15 Compounded Copyright© PerformRx, LLC 2015 All Rights Reserved Class Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Reason for recall Recalling firm Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Lack of Assurance of Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc Lincare, Inc 43 Product type Product description 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only Code info. Class Reason for recall Drugs Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only on 05/29/15, Discard After: 06/12/15 Compounded on 05/27/15, Discard After: 06/24/15 Drugs OXYCODONE HCl C-II Tablets, 5 mg USP, 100count blister cards, Rx only Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16 Drugs CONTRAVE (naltrexone HCl and bupropion HCl ) extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only Lot # B21642; Exp. 03/17 Class II Drugs Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only Lot #140849 Class II Failed dissolution specifications American Health Packaging Class II CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. Allegiant Health Class II Failed Dissolution Specifications; exceeded specification at the 9 hour time point Dr. Reddy's Laboratories, Inc. Class II Failed Dissolution Specifications; Dr. Reddy's Laboratories, Drugs Famotidine Tablets, USP, 20 mg Tablets, Over the Counter Drugs Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only Drugs Divalproex Sodium Extended-Release Tablets, Lot #: 3K34915, Expiry: 07/2015 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle Lot #C307859 and Lot# C307812, exp 09/2015 Lot #C308195, exp 10/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved Class II Class II Sterility: Sterility of product is not assured. Lack of Assurance of Sterility: Sterility of product is not assured. Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components Recalling firm Lincare, Inc The Harvard Drug Group, LLC Takeda Pharmaceutical s North America, Inc. 44 Product type Product description Code info. Class USP, 500 mg, 100 count bottles, Rx Only Drugs NEXIUM® (esomeprazole magnesium), DelayedRelease capsules, 20 mg, 30-count bottle, Rx only Lot # FC0064; Exp. 05/17 Class II Reason for recall Recalling firm exceeded specification at the 9 hour time point Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM® capsules contained 60 SEROQUEL® XR tablets Inc. AstraZeneca Pharmaceutical s LP CLASS III Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only Lot #:151360, Expiry: 12/31/2016 Drugs HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only 100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 06033968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16 Drugs Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx Lot #: 39-569DK, Exp 3/1/2016 Drugs Copyright© PerformRx, LLC 2015 All Rights Reserved Class III Class III Class III Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable Failed pH Specifications:12 month stability testing American Health Packaging Qualitest Pharmaceutical s Hospira Inc. 45 Product type Drugs Product description only Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC Code info. Lot #: 4D040, Exp 4/2016 Class Reason for recall Recalling firm Class III Subpotent Drug: menthol and methyl salicylate below specification BioComp Pharma, Inc. Drugs CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only Lot #: 04012015@45, Expiry: 09/28/2015 Drugs Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16 Drugs Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578035-05, b) 5 oz. Jar, NDC 10578-035-04 Lot # 6086221, Exp 10/16 Drugs E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only Lot #: 00513716, 00514712, Exp 03/2016 Class III Drugs Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only Lot #s: KPPY, Exp 06/15; NBXD, NBXF, Exp 10/16; NBXG, Exp 09/15; NKZS, Exp 11/15; NMPT, NNXB, NNWG, Exp Class III Copyright© PerformRx, LLC 2015 All Rights Reserved Class III Class III Class III Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution. Superpotent Drug: Product may not be uniformly blended resulting in nonuniform distribution of the active ingredient menthol. Failed stability specifications: This recall has been initiated due to out of specification results for viscosity. Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with outdated package inserts. Abrams Royal Pharmacy II, LLC Qualitest Pharmaceutical s Indiana Botanic Gardens, Inc Bracco Diagnostic Inc Actavis Inc 46 Product type Product description Code info. Class Reason for recall Recalling firm 01/16; NMPV, NVWN, NVWP, Exp 02/16; NMTP, NNXC, Exp 03/16; NMWC, NNXH, Exp 04/16; PFHT, PFHW, PFHX, Exp 06/16; PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ, Exp 08/16; PYDX, Exp 09/16. Drugs Drugs Drugs Drugs Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-32230), b) 90-count bottle (NDC 43598-322-90), Rx Lot #: F8011, Exp May 2015 Lot#: F0082, Exp May 2015 Lot #: 2625094, Exp 06/2016 Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015 Copyright© PerformRx, LLC 2015 All Rights Reserved Class III Class III Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. Novartis Pharmaceutical s Corp. Novartis Pharmaceutical s Corp. Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc. Class III Subpotent drug Dr. Reddy's Laboratories, Inc 47 Product type Drugs Drugs Drugs Drugs Product description Only Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-32130), b) 90-count bottle (NDC 43598-321-90), Rx Only Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90count bottle, Rx Only Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-31630), b) 90-count bottle (NDC 43598-316-90), Rx Only Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only Code info. Lot #: a) C401537, Exp 07/2015; b) C401539, Exp 07/2015 Class Class III Reason for recall Recalling firm Subpotent drug Dr. Reddy's Laboratories, Inc Lot # C309280 Class III Subpotent drug Dr. Reddy's Laboratories, Inc Lot # C402439 Class III Subpotent drug Dr. Reddy's Laboratories, Inc Class III Failed Impurities/Degradati on Specifications; 12 month stability testing (Expansion of RES #70548). West-Ward Pharmaceutical Corp. Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015 Vaccines Biologics None *Please refer to FDA website for further information; http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm Copyright© PerformRx, LLC 2015 All Rights Reserved 48 CURRENT DRUG SHORTAGES‡ Acetazolamide Injection June 25, 2015 Reason for the Shortage West-Ward is not actively marketing acetazolamide injection at this time. A Sagent has acetazolamide injection on shortage due to manufacturing delay. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=463 Source Link: http://www.ashp.org Boceprevir Capsules June 25, 2015 Reason for the Shortage Merck Sharp & Dohme has made a business decision to discontinue Victrelis capsules in the US by December 2015. Merck Sharp & Dohme is the sole supplier of boceprevir capsules. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1154 Source Link: http://www.ashp.org Cefotetan Disodium Injection June 25, 2015 Reason for the Shortage BBraun could not provide a reason for the shortage. Fresenius Kabi states the reason for the shortage is manufacturing delay Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1097 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 49 L-Cysteine Hydrochloride Injection Ondansetron Injection June 25, 2015 Reason for the Shortage American Regent has L-cysteine hydrochloride injection on back order due to manufacturing delays. Sandoz has L-cysteine in short supply due to requirements related to complying with good manufacturing practices. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=632 Source Link: http://www.ashp.org Ondansetron Injection June 26, 2015 Reason for the Shortage AuroMedics did not provide a reason for the shortage. Fresenius Kabi has ondansetron injection on back order due to increased demand. Heritage cannot provide a reason for the shortage. Sagent has ondansetron on back order due to increased demand. The Medicines Company will no longer be supplying ondansetron. West-Ward had ondansetron on back order due to increased demand. Wockhardt has ondansetron injection on an FDA import alert. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1040 Source Link: http://www.ashp.org Cefpodoxime June 29, 2015 Reason for the Shortage Ranbaxy has an import ban on all solid medications including cefpodoxime. Aurobindo could not provide a reason for the shortage. Pfizer has discontinued Vantin. Sandoz could not provide a reason for the shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 50 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=793 Source Link: http://www.ashp.org Fomepizole Injection June 29, 2015 Reason for the Shortage Sandoz could not provide a reason for the shortage. However, fomepizole injection is manufactured by Emcure for Sandoz. An Emcure manufacturing site was recently noted to have FDA observations related to GMP and aseptic practices. X-Gen could not provide a reason for the shortage. Mylan Institutional could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1173 Source Link: http://www.ashp.org Heparin Premixed Bags June 29, 2015 Reason for the Shortage Baxter and BBraun had product on allocation due to increased demand. Hospira states the reason for the shortage is manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1169 Source Link: http://www.ashp.org Phytonadione (Vitamin K) Injection June 29, 2015 Reason for the Shortage Amphastar has vitamin K injection on shortage due to increased demand for the product. Oral vitamin K is not affected by this shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 51 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=852 Source Link: http://www.ashp.org Indigo Carmine Injection June 30, 2015 Reason for the Shortage American Regent has indigo carmine on back order due to manufacturing delays. Akorn has discontinued production of indigo carmine due to shortage of raw material. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=861 Source Link: http://www.ashp.org Phenazopyridine Hydrochloride Atorvastatin Tablets June 30, 2015 Reason for the Shortage Amneal Pharmaceuticals, Avkare, SDA Laboratories discontinued phenazopyridine tablets. Marlex could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1144 Source Link: http://www.ashp.org Atorvastatin Tablets July 1, 2015 Reason for the Shortage Ranbaxy discontinued atorvastatin in late-2014. Apotex has atorvastatin tablets on allocation due to increased demand. Greenstone and Sandoz state the shortage is due to demand exceeding supply. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=989 Copyright© PerformRx, LLC 2015 All Rights Reserved 52 Source Link: http://www.ashp.org Cefuroxime Sodium Injection Chlorpromazine Injection July 1, 2015 Reason for the Shortage Sagent suspended the manufacture of cefuroxime injection. BBraun, Fresenius Kabi, and Hospira discontinued manufacturing cefuroxime in 2013. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=990 Source Link: http://www.ashp.org Chlorpromazine Injection July 1, 2015 Reason for the Shortage West-Ward has chlorpromazine injection on shortage due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1188 Source Link: http://www.ashp.org Dexrazoxane Injection July 1, 2015 Reason for the Shortage West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired dexrazoxane injection from Bedford in July 2014. West-Ward is not actively marketing dexrazoxane injection at this time. Biocodex USA acquired Totect from Apricus Pharmaceuticals in April 2013. Mylan Institutional cannot provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=415 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 53 Doxorubicin Liposomal Injection July 1, 2015 Reason for the Shortage Janssen Products, LP states the shortage is due to manufacturing issues. Janssen Products, LP has updates with information about the shortage on the Doxil website that is updated regularly. FDA approved a new manufacturer of Doxil in January 2015. Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. Caraco launched generic doxorubicin liposomal injection in mid-March 2013 and can supply the market with their presentations. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=806 Source Link: http://www.ashp.org Methotrexate Injection July 1, 2015 Reason for the Shortage Mylan Institutional cannot provide a reason for the shortage. Sandoz discontinued methotrexate 2 mL and 10 mL vials. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including methotrexate injection. West-Ward is not actively marketing methotrexate injection. Teva has methotrexate on short-term back order for standard quality control. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=26 Source Link: http://www.ashp.org Sodium Bicarbonate Injection July 1, 2015 Reason for the Shortage Hospira has sodium bicarbonate on shortage due to increased demand. Hospira is the sole supplier of the 4.2% 10 mL syringes used in pediatric patients. Amphastar has sodium bicarbonate on shortage due to increased demand and has a new NDC number for the product. Copyright© PerformRx, LLC 2015 All Rights Reserved 54 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=788 Source Link: http://www.ashp.org Ciprofloxacin Immediate-Release Tablets July 2, 2015 Reason for the Shortage Ranbaxy has an FDA import ban on several of their products manufactured in India. Carlsbad Technology discontinued ciprofloxacin tablets in 2014. Marlex is unable to provide a reason for their shortage. Major discontinued their ciprofloxacin immediate-release tablets in February, 2010. Teva discontinued their ciprofloxacin immediate-release tablet, unit dose presentations in June, 2010. Schering has discontinued all Cipro immediate-release tablet presentations. UDL has discontinued all ciprofloxacin immediate-release 250 mg unit-dose tablets. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=572 Source Link: http://www.ashp.org Dextran Low Molecular Weight (Dextran 40), 10% Injection July 2, 2015 Reason for the Shortage Hospira states the reason for the shortage is manufacturing delay and increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1108 Source Link: http://www.ashp.org Pramipexole Dihydrochloride Tablets July 2, 2015 Reason for the Shortage Aurobindo, Mylan, and Sandoz cannot provide a reason for the shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 55 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1131 Source Link: http://www.ashp.org Sodium Phosphate Injection July 2, 2015 Reason for the Shortage American Regent has sodium phosphate injection on back order due to manufacturing delays. American Regent has issued a statement that all lots of sodium phosphate have potential for crystallization. Do not use if any particles are present. Hospira had sodium phosphate injection on shortage due to manufacturing delays. In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. Fresenius Kabi launched sodium phosphate injection in mid-January 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=770 Source Link: http://www.ashp.org Digoxin Injection July 5, 2015 Reason for the Shortage West-Ward states the shortage is due to manufacturing delays.. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=748 Source Link: http://www.ashp.org Metoprolol Injection July 5, 2015 Reason for the Shortage Copyright© PerformRx, LLC 2015 All Rights Reserved 56 American Regent has metoprolol injection on shortage due to manufacturing delays. Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Claris has metoprolol injection available. Fresenius Kabi states the shortage is due to increased demand for the product. Hospira states the shortage is due to increased demand for the product. Novartis discontinued Lopressor injection in mid-2015. Sagent states the shortage is due to increased demand for the product. Sandoz cannot provide a reason for the shortage. West-Ward had metoprolol injection available. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=813 Source Link: http://www.ashp.org Ammonium Chloride Injection July 7, 2015 Reason for the Shortage Hospira states the shortage of ammonium chloride is due to manufacturing delays. Hospira is the sole manufacturer of ammonium chloride injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=933 Source Link: http://www.ashp.org Electrolyte Concentrate July 7, 2015 Reason for the Shortage American Regent has Nutrilyte and Nutrilyte on back order due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1054 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 57 Lactated Ringer’s Injection Bags July 7, 2015 Reason for the Shortage Baxter has lactated ringers on shortage due to increased demand. BBraun has lactated ringers on allocation due to increased demand. Hospira cited increased demand as the reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1078 Source Link: http://www.ashp.org Nebivolol Tablets July 7, 2015 Reason for the Shortage Actavis could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1137 Source Link: http://www.ashp.org Sodium Chloride 0.9% Irrigation July 7, 2015 Reason for the Shortage Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays. BBraun has 0.9% sodium chloride irrigation on shortage due to increased demand and only has product available for existing customers. Hospira has 0.9% sodium chloride irrigation on shortage due manufacturing delays and only has product available for existing customers. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1118 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 58 Sodium Chloride 0.9% Injection Bags July 7, 2015 Reason for the Shortage Baxter has 0.9% sodium chloride on shortage due to increased demand. BBraun had 0.9% sodium chloride on allocation due to increased demand. Hospira cites increased demand as the reason for the shortage. In cooperation with the FDA, Fresenius Kabi is providing 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. There will be presentations available with Australian/English label and the package insert is the same for all imported presentations. In cooperation with the FDA, Baxter is providing 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride in Viaflo containers is manufactured in an FDA-approved facility in Spain by Baxter. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=993 Source Link: http://www.ashp.org Vecuronium Bromide Injection July 7, 2015 Reason for the Shortage Hospira states the shortage is due to manufacturing delays. Teva states the shortage is due to manufacturing delays. Pfizer sold vecuronium injection to Mylan Institutional in December 2013. Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. Caraco has vecuronium injection available. NDCs changed in mid-2015. Sagent temporarily suspended the manufacture of vecuronium 10 mg and 20 mg vials. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=490 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 59 Caffeine and Sodium Benzoate Injection July 8, 2015 Reason for the Shortage American Regent had caffeine and sodium benzoate injection on shortage due to manufacturing delays. American Regent is the sole manufacturer of caffeine and sodium benzoate injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=817 Source Link: http://www.ashp.org Carboplatin Solution for Injection July 8, 2015 Reason for the Shortage Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products. Fresenius Kabi has carboplatin on shortage due to increased demand for the product. Hospira has carboplatin injection available. Mylan Institutional cannot provide a reason for the shortage. Sagent has carboplatin injection available. Sandoz has discontinued carboplatin injection. Teva had carboplatin injection on short-term back order due to standard quality inspections. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1005 Source Link: http://www.ashp.org Doxorubicin Injection July 8, 2015 Reason for the Shortage West-Ward Pharmacetuicals’ parent company, Hikma Pharmaceuticals, acquired Adriamycin injection from Bedford in July 2014. West-Ward is not actively marketing Adriamycin injection at this time. Teva has doxorubicin solution for injection available. Fresenius Kabi has doxorubicin solution for injection available. Copyright© PerformRx, LLC 2015 All Rights Reserved 60 Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials. Pfizer had doxorubicin solution for injection on shortage due to shipping delays. Sagent has doxorubicin solution for injection on shortage due to increased demand. Mylan cannot provide a reason for the reason for the doxorubicin solution for injection available. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=464 Source Link: http://www.ashp.org Lactated Ringer's Irrigation July 8, 2015 Reason for the Shortage Baxter has lactated ringer’s on shortage due manufacturing delays. BBraun has lactated ringer’s irrigation on shortage due to increased demand. Hospira has lactated ringer’s irrigation on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1119 Source Link: http://www.ashp.org Mesna Injection July 8, 2015 Reason for the Shortage Fresenius Kabi had mesna on shortage due to increased demand. Mylan could not give a reason for the shortage of mesna. Sagent has mesna on shortage due to manufacturing delays. Teva had a shortage of mesna injection due to manufacturing delays. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired mesna injection from Bedford in July 2014. West-Ward is not actively marketing mesna injection at this time. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1148 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 61 Milrinone Injection July 8, 2015 Reason for the Shortage Fresenius Kabi states the reason for the shortage is increased demand for the product. Hospira has milrinone injection on shortage due to increased demand. West-Ward states the shortage is due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=741 Source Link: http://www.ashp.org Pantoprazole Injection July 8, 2015 Reason for the Shortage Pfizer has Protonix on shortage due to increased demand. Pfizer is the sole supplier of pantoprazole injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1153 Source Link: http://www.ashp.org Promethazine Injection July 8, 2015 Reason for the Shortage Teva states the shortage is due to manufacturing delays. West-Ward states the shortage was due to manufacturing delays. Hospira states the shortage is due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=654 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 62 Acamprosate Calcium Tablets July 9, 2015 Reason for the Shortage Glenmark Pharmaceuticals could not provide a reason for the shortage. Mylan cannot provide a reason for the shortage. Actavis discontinued Campral tablets in 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1170 Source Link: http://www.ashp.org Adenosine Injection July 9, 2015 Reason for the Shortage Astellas discontinued Adenoscan in April 2015. Adenoscan is used for diagnostic purposes as an adjunct to thallium-201 myocardial perfusion scintigraphy. Adenocard and generic adenosine products are labeled for use in paroxysmal supraventricular tachycardia. Sagent has adenosine vials on shortage due to increased demand. West-Ward could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=976 Source Link: http://www.ashp.org Amoxicillin 875 mg Tablets July 9, 2015 Reason for the Shortage Aurobindo had amoxicillin on shortage due to manufacturing delays. Citron Pharma supplies product to current customers. Dr Reddy’s discontinued amoxicillin 875 mg tablets in June 2014. Ranbaxy has an FDA import ban on amoxicillin tablets. Sandoz cannot provide a reason for the shortage. West-Ward has amoxicillin on shortage due to increased demand. Article Link: Copyright© PerformRx, LLC 2015 All Rights Reserved 63 http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1141 Source Link: http://www.ashp.org Azathioprine Tablets July 9, 2015 Reason for the Shortage Roxane discontinued azathioprine tablets in mid-January 2015 due to problems obtaining active ingredient. Valeant acquired Salix Pharmaceuticals in April 2015. Mylan could not provide a reason for the shortage. Prometheus Laboratories states the reason for the shortage was increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1123 Source Link: http://www.ashp.org Carbidopa and Levodopa Extended-Release Tablets July 9, 2015 Reason for the Shortage Caraco could not provide a reason for the shortage. Merck could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1181 Source Link: http://www.ashp.org Dexamethasone Sodium Phosphate July 9, 2015 Reason for the Shortage American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays. Fresenius Kabi states the dexamethasone sodium phosphate shortage is due to supply and demand issues. Copyright© PerformRx, LLC 2015 All Rights Reserved 64 West-Ward had dexamethasone sodium phosphate injection on shortage due to increased demand. Mylan Institutional states the shortage is due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=751 Source Link: http://www.ashp.org Ketorolac Tromethamine Injection July 9, 2015 Reason for the Shortage Fresenius Kabi has ketorolac injection available. Hospira has ketorolac on shortage due to manufacturing delays for quality improvement activities and increased demand for the product. Hospira issued a voluntary recall of several presentations of ketorolac in January 2015 due to potential for particulate matter. Sagent states the reason for the shortage is demand exceeding supply. West-Ward has ketorolac injection on shortage due to manufacturing delays. Ben Venue closed its plant in Bedford, Ohio in July 2014. FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. Sprix Nasal Spray is not affected by this shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=593 Source Link: http://www.ashp.org Leuprolide Acetate 14-Day Kit July 9, 2015 Reason for the Shortage Caraco has a new NDC number for the leuprolide injection. Teva states the shortage is due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=737 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 65 Methylphenidate Hydrochloride Chewable Tablets July 9, 2015 Reason for the Shortage Shionogi Pharma has Methylin chewable tablets on shortage due to manufacturing issues. Gavis launched methylphenidate chewable tablets in April 2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1163 Source Link: http://www.ashp.org Nimodipine Oral Solution July 9, 2015 Reason for the Shortage Arbor has Nymalize oral solution on temporary back order due to shortage of an active ingredient. Nimodipine oral capsules are not affected by this shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1191 Source Link: http://www.ashp.org Sufentanil Injection July 9, 2015 Reason for the Shortage West-Ward had sufentanil on shortage due to manufacturing delays. Hospira has sufentanil on shortage due to manufacturing delays. Akorn could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=823 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 66 Testosterone Cypionate Intramuscular Injection July 9, 2015 Reason for the Shortage Actavis discontinued testosterone cypionate injection in 2015. Paddock has testosterone on shortage due to increased demand and shipping delays from their contract manufacturer. West-Ward had testosterone cypionate on shortage due to manufacturing delays. Sandoz discontinued testosterone cypionate 200 mg/mL 1 mL and 10 mL vials in September 2011. Sandoz discontinued final presentation in first half of 2012. Sun Pharmaceuticals could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=638 Source Link: http://www.ashp.org Vancomycin Hydrochloride Injection July 9, 2015 Reason for the Shortage Hospira has vancomycin on shortage due to increased demand. Fresenius Kabi has vancomycin injection on shortage due to increased demand. Mylan Institutional cannot provide a reason for the shortage. Baxter is allocating vancomycin. Sagent has vancomycin injection on allocation due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=132 Source Link: http://www.ashp.org Atropine Sulfate Injection July 10, 2015 Reason for the Shortage American Regent states the shortage was due to manufacturing delays. Hospira states the shortage is due to manufacturing delays. Amphastar has atropine on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=814 Copyright© PerformRx, LLC 2015 All Rights Reserved 67 Source Link: http://www.ashp.org Furosemide Injection July 10, 2015 Reason for the Shortage Fresenius Kabi has furosemide injection on shortage due to increased demand for the product. American Regent has furosemide injection on shortage due to manufacturing delays. Hospira has furosemide injection available. Wockhardt has discontinued all furosemide injection presentations. Claris could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=636 Source Link: http://www.ashp.org Imipenem Cilastatin Injection July 10, 2015 Reason for the Shortage Fresenius has imipenem-cilastatin injection on shortage due to short expiration dating. Hospira has imipenem-cilastatin injection on shortage due to manufacturing delays. Merck cannot provide a reason for the shortage of Primaxin injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1182 Source Link: http://www.ashp.org Lidocaine Injection July 10, 2015 Reason for the Shortage Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product. AuroMedics introduced lidocaine injection in February 2014. Fresenius Kabi has Xylocaine and lidocaine presentations on shortage due to increased demand for the product. Copyright© PerformRx, LLC 2015 All Rights Reserved 68 Hospira has lidocaine presentations on shortage due to manufacturing delays and increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=859 Source Link: http://www.ashp.org Meningococcal Vaccines July 10, 2015 Reason for the Shortage Sanofi Pasteur cannot provide a reason for the shortage. GlaxoSmithKline acquired Bexsero and Menveo from Novartis Vaccines and Diagnostics in 2015. The company could not provide a reason for the shortage of Bexaro. Pfizer has Trumenba available. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1192 Source Link: http://www.ashp.org Methylene Blue Injection July 10, 2015 Reason for the Shortage Akorn has methylene blue on back order due to manufacturing delays. American Regent has methylene blue on back order due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=27 Source Link: http://www.ashp.org Ofloxacin Otic Solution July 10, 2015 Reason for the Shortage Apotex discontinued ofloxacin otic solution in early 2015. Sandoz cannot provide a reason for the shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 69 Valeant cannot provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1187 Source Link: http://www.ashp.org Valproate Sodium Injection July 10, 2015 Reason for the Shortage Fresenius Kabi states the reason for the shortage was manufacturing delay. West-Ward could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=842 Source Link: http://www.ashp.org Amikacin Injection July 13, 2015 Reason for the Shortage West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired amikacin injection from Bedford in July 2014. West-Ward is not actively marketing amikacin 250 mg/mL 4 mL vials at this time. Teva’s product was unavailable due to manufacturing delays. Heritage has amikacin injection on shortage due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=501 Source Link: http://www.ashp.org Chorionic Gonadotropin (Human) Injection July 13, 2015 Reason for the Shortage Merck states their product is on allocation to prevent use in the gray market. Copyright© PerformRx, LLC 2015 All Rights Reserved 70 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=382 Source Link: http://www.ashp.org Desmopressin Injection July 13, 2015 Reason for the Shortage Teva and Hospira have desmopressin injection on shortage due to manufacturing delays. Ferring acquired marketing rights of DDAVP from Sanofi in October 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1010 Source Link: http://www.ashp.org Dextrose (50%) Injection July 13, 2015 Reason for the Shortage Amphastar has 50% dextrose injection on shortage due to increased demand. Hospira has 50% dextrose injection on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1012 Source Link: http://www.ashp.org Ethiodized Oil July 13, 2015 Reason for the Shortage Guerbet states their Lipiodol product is in short supply due to manufacturing problems at Jubliant HollisterStier, the manufacturing site in Canada that supplies Lipiodol for Guerbet. The company estimates the shortage will last at least one year. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=618 Copyright© PerformRx, LLC 2015 All Rights Reserved 71 Source Link: http://www.ashp.org Propranolol Hydrochloride Tablets July 13, 2015 Reason for the Shortage Actavis cannot provide a reason for the shortage. Heritage states the reason for the shortage is a raw materials issue. Northstar discontinued all propranolol tablets in February 2015. Mylan could not provide a reason for the shortage. Qualitest refuses to provide product availability as the company considers it proprietary information. Teva could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1189 Source Link: http://www.ashp.org Tacrolimus Capsules July 13, 2015 Reason for the Shortage Novartis discontinued all Hecoria presentations in February 2015. Mylan discontinued the 500 count presentations in early 2015. Mylan could not provide a reason for the shortage. Sandoz states the reason for the shortage was manufacturing delay. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1149 Source Link: http://www.ashp.org 14.6% Sodium Chloride Concentrated Solution for Injection July 14, 2015 Reason for the Shortage Hospira has 14.6% sodium chloride solutions for injection on shortage due to manufacturing delays. Copyright© PerformRx, LLC 2015 All Rights Reserved 72 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1195 Source Link: http://www.ashp.org 23.4% Sodium Chloride Concentrated Solution for Injection July 14, 2015 Reason for the Shortage Fresenius Kabi has sodium chloride concentrated solution on shortage due to increased demand. Hospira has 23.4% sodium chloride solutions for injection on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1194 Source Link: http://www.ashp.org Atenolol Tablets July 14, 2015 Reason for the Shortage AstraZeneca divested Tenormin to Almatica in January 2015. Almatica has new NDC numbers for Tenormin tablets. Pack Pharmaceuticals discontinued atenolol tablets in October 2014. Ranbaxy has atenolol tablets on shortage due to manufacturing delays. Zydus has atenolol tablets on allocation due to increased demand. Aurobindo and Caraco have discontinued atenolol tablets. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1127 Source Link: http://www.ashp.org Buprenorphine Sublingual Tablets July 14, 2015 Reason for the Shortage Teva could not provide a reason for the shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 73 Akorn acquired Hi-Tech Pharmacal in 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1030 Source Link: http://www.ashp.org Etomidate Injection July 14, 2015 Reason for the Shortage American Regent has etomidate injection on shortage due to manufacturing delays. Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Hospira has Amidate injection on shortage due to increased demand. Par Sterile Products discontinued etomidate in early 2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=419 Source Link: http://www.ashp.org Mercaptopurine Tablets July 14, 2015 Reason for the Shortage Par discontinued mercaptopurine tablets in October 2014. Teva discontinued mercaptopurine generic and Purinethol in mid-2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=997 Source Link: http://www.ashp.org Midazolam Injections July 14, 2015 Reason for the Shortage West-Ward acquired Baxter’s midazolam injection products in May, 2011. Ben Venue stopped production in its plant in Bedford, Ohio and closed in 2014. Copyright© PerformRx, LLC 2015 All Rights Reserved 74 Hospira has midazolam on shortage due to manufacturing delays and demand exceeding supply due to current market conditions. Fresenius Kabi had midazolam on shortage due to increased demand. Due to low demand, Akorn is focusing on other medications that are in greater need of supply. Sagent has midazolam on shortage due to manufacturing delay. Caraco has discontinued all midazolam presentations. Caraco discontinued two midazolam presentations in 2014. FDA imposed an import ban in mid-2013 on several Wockhardt products including midazolam injection. Medicines Company is no longer carrying midazolam injection. BD RX introduced midazolam injection in 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=858 Source Link: http://www.ashp.org Morphine Injections July 14, 2015 Reason for the Shortage Fresenius Kabi states the shortage is due to a change in manufacturing sites and cannot estimate when Astramorph will return. Hospira states the shortage is due to manufacturing delays. West-Ward states the shortage was due to increased demand for product. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=664 Source Link: http://www.ashp.org Piperacillin Tazobactam Injection July 14, 2015 Reason for the Shortage Apotex has piperacillin/tazobactam on shortage due to regulatory delays. AuroMedics and Sandoz could not provide a reason for the shortage. Baxter has Zosyn frozen premixes on allocation due to increased demand. Fresenius Kabi has piperacillin/tazobactam on shortage due to increased demand. Hospira has piperacillin/tazobactam on shortage due to manufacturing delays. Copyright© PerformRx, LLC 2015 All Rights Reserved 75 Sagent has piperacillin/tazobactam on shortage due to increased demand. Pfizer has Zosyn on shortage due to manufacturing delays. Pfizer estimates there will be supply shortages through September 2015 for the single dose vials and 1st quarter 2017 for the bulk vials. WG Critical Care states the reason for the shortage is increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1075 Source Link: http://www.ashp.org Ranitidine Injection July 14, 2015 Reason for the Shortage West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired ranitidine injection from Bedford in July 2014. West-Ward discontinued ranitidine injection in September 2014. Covis has Zantac on shortage due to capacity issues at the manufacturer. Oral ranitidine products are not affected by this shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=820 Source Link: http://www.ashp.org Sterile Water Irrigation July 14, 2015 Reason for the Shortage Baxter had sterile water for irrigation on shortage due manufacturing delays. BBraun only has product available for existing customers. Hospira only has product available for existing customers. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1120 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 76 Sumatriptan Succinate Injection July 14, 2015 Reason for the Shortage Sagent states the reason for the shortage is increased demand. GlaxoSmithKline has product available with short expiration dating. Pfizer has had Alsuma on shortage since September 2013 due to manufacturing issues. Zogenix sold Sumavel DosePro to Endo in 2014. Teva has temporarily suspended the production of sumatriptan injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1085 Source Link: http://www.ashp.org Thiotepa for Injection July 14, 2015 Reason for the Shortage West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including thiotepa injection. WestWard discontinued thiotepa injection in September 2014. FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne SA in Italy. Product may be ordered directly through Adienne SA. The solution is similar in formulation to US thiotepa. The main differences between the two products are listed below: o Tepadina comes in 15 mg and 100 mg vials while the US thiotepa from Bedford only comes in a 15 mg vial. Reconstitution of the products should still yield a final concentration of 10 mg/mL and therefore use caution in choosing vial size and volume of diluent. o Tepadina is indicated for different uses and therefore different dosing regimens are on the Europe labeling compared to US labeling, but it is the same product as in the US. o The bar coding for the Italian product will not provide correct information to bar code readers since the manufacturing code is not an NDC number. More information on the product packaging and ordering procedures can be found online. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=589 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 77 Amino Acid Products July 15, 2015 Reason for the Shortage Baxter has all amino acid products available to current customers. BBraun has Plenamine and TrophAmine on allocation due to increased demand. Hospira has amino acid products on back order due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=671 Source Link: http://www.ashp.org Calcium Chloride Injection July 15, 2015 Reason for the Shortage American Regent has calcium chloride on shortage due to manufacturing delays. Amphastar had calcium chloride on shortage due to increased demand. Hospira has calcium chloride on shortage due to increased demand. Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=941 Source Link: http://www.ashp.org Acetylcysteine Inhalation Solution July 16, 2015 Reason for the Shortage American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014. Hospira has consistent supply of acetylcysteine oral and inhalation solution. Fresenius Kabi states the reason for the shortage was increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=932 Copyright© PerformRx, LLC 2015 All Rights Reserved 78 Source Link: http://www.ashp.org Ceftriaxone Sodium Injection July 16, 2015 Reason for the Shortage Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Fresenius Kabi states the reason for the shortage is increased demand. Hospira has a consistent supply of ceftriaxone injection. Sagent states the reason for the shortage is increased demand. Sandoz cannot provide a reason for the shortage. WG Critical Care states the reason for the shortage is increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1101 Source Link: http://www.ashp.org Ephedrine Injection July 16, 2015 Reason for the Shortage Hospira discontinued ephedrine in March, 2011. Sandoz discontinued ephedrine in summer 2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=351 Source Link: http://www.ashp.org Lorazepam injectable presentations July 16, 2015 Reason for the Shortage Bedford discontinued lorazepam in May, 2011 to concentrate on the manufacturing of other products. West-Ward acquired Baxter’s lorazepam injection products in May, 2011. NDC numbers for the lorazepam and Ativan products were changed in April, 2012. West-Ward had Ativan on back order due to increase surplus of the lorazepam presentations. Hospira has consistent supply of lorazepam injection. Copyright© PerformRx, LLC 2015 All Rights Reserved 79 Akorn increased production to help meet demand. Amphastar had lorazepam 2 mg/mL vials on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=747 Source Link: http://www.ashp.org Magnesium Sulfate Injection July 16, 2015 Reason for the Shortage American Regent has magnesium sulfate on shortage due to manufacturing delays. Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for the product. Hospira has consistent supply of magnesium sulfate injection. X-Gen has magnesium sulfate injection on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=757 Source Link: http://www.ashp.org Potassium Chloride Injection July 16, 2015 Reason for the Shortage Baxter has a consistent supply of potassium chloride injection. Hospira has a consistent supply of potassium chloride injection. Fresenius Kabi could not provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=696 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 80 Rocuronium Injection July 16, 2015 Reason for the Shortage Merck discontinued Zemuron 10 mL multidose vials in the 3rd Quarter of 2013. Merck discontinued Zemuron 5 mL vials in June 2014. Mylan Institutional states the reason for the shortage was increased demand. Hospira has a consistent supply of rocuronium injection. Teva has rocuronium on shortage due to manufacturing delays. Fresenius Kabi has rocuronium injection available. Sagent cites increased demand as the reason for this shortage. Sandoz has rocuronium injection available. The Medicines Company is no longer supplying rocuronium injection. X-Gen has rocuronium injection available. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=434 Source Link: http://www.ashp.org Succinylcholine chloride Injection July 16, 2015 Reason for the Shortage Hospira has a consistent supply of Quelicin injection. Sandoz has Anectine on shortage due to extra quality reviews. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=582 Source Link: http://www.ashp.org Verapamil Injection July 16, 2015 Reason for the Shortage Hospira has verapamil injection on shortage due to increased demand for the product. Hospira is the sole supplier of verapamil injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=744 Copyright© PerformRx, LLC 2015 All Rights Reserved 81 Source Link: http://www.ashp.org Aripiprazole Oral Disintegrating Tablets July 17, 2015 Reason for the Shortage Otsuka has discontinued Abilify Discmelt oral disintegrating tablets. The company has also discontinued the oral solution and injection. There are no other suppliers of aripiprazole oral disintegrating tablets. Abilify oral tablets and generic aripiprazole oral tablets are not affected. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1198 Source Link: http://www.ashp.org Atracurium Injection July 17, 2015 Reason for the Shortage West-Ward discontinued atracurium in September 2014. Hospira has atracurium available. Sagent has atracurium on shortage due to product recall. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=872 Source Link: http://www.ashp.org Benzonatate Capsules July 17, 2015 Reason for the Shortage Amneal and Ascend Laboratories cannot provide a reason for the shortage. Caraco discontinued benzonatate capsules in mid-2015. Zydus states the reason for the shortage is manufacturing delay. Pfizer had Tessalon Perles on shortage due to supply and demand issues. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1155 Copyright© PerformRx, LLC 2015 All Rights Reserved 82 Source Link: http://www.ashp.org Bupivacaine Injection July 17, 2015 Reason for the Shortage Fresenius Kabi has Sensorcaine on shortage due to increased demand for the product. Hospira has bupivacaine on shortage due to manufacturing delays. AuroMedics introduced bupivacaine injection in February 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=864 Source Link: http://www.ashp.org Cisplatin Injection July 28, 2015 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1198 Source Link: http://www.ashp.org Disopyramide Phosphate Controlled-release Capsules July 17, 2015 Reason for the Shortage Pfizer has Norpace CR on shortage due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1139 Source Link: http://www.ashp.org Ethambutol Tablets July 17, 2015 Reason for the Shortage Akorn acquired VersaPharm, Inc. in 2014. Copyright© PerformRx, LLC 2015 All Rights Reserved 83 Akorn could not provide a reason for the shortage. X-Gen could not provide a reason for the shortage. G&W Laboratories discontinued ethambutol tablets in mid-April 2013. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=982 Source Link: http://www.ashp.org Labetalol Injection July 17, 2015 Reason for the Shortage Hospira has labetalol on shortage due to increased demand. Sagent suspended production on labetalol 5 mg/mL 20 mL vials (NDC 25021-0300-20) in July 2013 and 40 mL vials in February 2014 (NDC 25021-0300-40) and the company has no estimated release date for further production. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including labetalol injection. WestWard is not actively marketing labetalol injection. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=397 Source Link: http://www.ashp.org Lidocaine with Epinephrine Injection July 17, 2015 Reason for the Shortage Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product. Hospira had lidocaine with epinephrine presentations on shortage due to manufacturing delays and increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=860 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 84 Acetaminophen and Codeine Phosphate 300 mg/30 mg Tablets July 20, 2015 Reason for the Shortage Mallinckrodt states the shortage is due a variety of market conditions. Aurobindo and Mylan cannot provide a reason for the shortage. Janssen cannot provide a reason for the shortage. Qualitest will not provide shortage information for any of their products because they consider the information to be proprietary. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1152 Source Link: http://www.ashp.org Ampicillin Sulbactam July 20, 2015 Reason for the Shortage AuroMedics Pharma launched new product in mid-June, 2012. Hospira states that ampicillin sulbactam vials are on back order due to manufacturing delay. Mylan Institutional discontinued ampicillin sulbactam injection in late 2013. Sagent has ampicillin sulbactam vials on allocation due to increased demand for the product. WG Critical Care states the shortage is due to increased demand. Pfizer and Sandoz cannot provide a reason for the shortage. WG Critical Care launched ampicillin sulbactam 1.5 gram vials in March 2014. West-Ward acquired several Baxter products in early 2011. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=805 Source Link: http://www.ashp.org Aprepitant Capsules July 20, 2015 Reason for the Shortage Merck is the sole supplier of Emend (aprepitant) capsules. Merck states the reason for this shortage is increased demand. Copyright© PerformRx, LLC 2015 All Rights Reserved 85 Emend injection is not affected by this shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=881 Source Link: http://www.ashp.org Atropine Sulfate Ophthalmic Solution July 20, 2015 Reason for the Shortage Alcon has Isopto Atropine only available through wholesalers and not available for direct order. Akorn received FDA approval for atropine sulfate 1% ophthalmic solution in July 2014; this new product launched in January 2015. All other atropine sulfate ophthalmic solution products are unapproved products. Sandoz could not provide a reason for the shortage. Valeant discontinued their atropine sulfate 1% ophthalmic solution products in 2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1146 Reason for the Shortage Alcon has Isopto Atropine only available through wholesalers and not available for direct order. Source Link: http://www.ashp.org Cardioplegic Solution for Cardiac Perfusion July 20, 2015 Reason for the Shortage Baxter states the reason for the shortage is increased demand. Hospira states the reason for the shortage is manufacturing delay. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1172 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 86 Deferoxamine Mesylate Injection July 20, 2015 Reason for the Shortage Fresenius Kabi states the shortage was due to increased demand. Hospira has deferoxamine in short supply due to shortage of an active ingredient and increased demand. Teva discontinued all deferoxamine presentations in 2013. West-Ward discontinued deferoxamine in September 2014. Watson discontinued all deferoxamine presentations. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1008 Source Link: http://www.ashp.org Hydroxyamphetamine Hydrobromide and Tropicamide Ophthalmic Solution July 20, 2015 Reason for the Shortage Akorn discontinued Paredrine ophthalmic solution in 1999. Letco Medical discontinued hydroxyamphetamine powder in 2007. Spectrum discontinued hydroxyamphetamine powder in 2010. Professional Compounding Centers of America (PCCA) had previously supplied hydroxyamphetamine powder (NDC 51927-2239-00) to pharmacies who were members of the organization. PCCA does not provide any information regarding product availability to non-members. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1193 Source Link: http://www.ashp.org Leflunomide Tablets July 20, 2015 Reason for the Shortage Apotex has temporarily discontinued leflunomide and cannot state if they will bring the product back to market. Heritage states the shortage is due to a delay in obtaining active ingredient. Sanofi-Aventis could not provide a reason for the shortage. Copyright© PerformRx, LLC 2015 All Rights Reserved 87 Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=711 Source Link: http://www.ashp.org Sterile Water for Injection Large Volume Bags July 20, 2015 Reason for the Shortage Baxter had sterile water for injection on shortage due manufacturing delays. BBraun has sterile water for injection on shortage due to increased demand and only has product available for existing customers. Hospira has sterile water for injection available for existing customers. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1132 Source Link: http://www.ashp.org Tamsulosin Hydrochloride Capsules July 20, 2015 Reason for the Shortage Boehringer Ingelheim could not provide a reason for the shortage. Actavis and Zydus state the reason for the shortage is increased demand. Aurobindo is not marketing the 100 count size. Caraco cannot provide a reason for the shortage. Teva discontinued tamsulosin 0.4 mg capsules in April 2014. Par discontinued tamsulosin 0.4 mg capsules. Sandoz has tamsulosin on shortage due to increased demand for the product. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1112 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 88 Ceftazidime Injection July 21, 2015 Reason for the Shortage Covis had Fortaz premixed bags on shortage due to increased demand. Hospira has Tazicef on shortage due to increased demand. Sagent has ceftazidime injection on shortage due to manufacturing delays Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=869 Source Link: http://www.ashp.org Clindamycin Injection July 21, 2015 Reason for the Shortage Pfizer states the Cleocin Add-Vantage vials are on shortage due to manufacturing delays. Hospira had clindamycin injection on shortage due to manufacturing delays. Sandoz had clindamycin injection on shortage due to increased demand. Sagent has clindamycin injection on shortage due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1029 Source Link: http://www.ashp.org Bupropion Hydrochloride 24 hour ER Tablets July 22, 2015 Reason for the Shortage Actavis began transitioning to new NDC numbers in February 2015. Par states the reason for the shortage was increased demand for product. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1106 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 89 Chloroquine Tablets July 22, 2015 Reason for the Shortage Global Pharmaceuticals discontinued chloroquine tablets in 2014. Rising discontinued chloroquine tablets in February 2015. Ranbaxy has chloroquine tablets on shortage due to third party supply issues. West-Ward cannot provide a reason for the shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1178 Source Link: http://www.ashp.org Dextrose 5% Injection Large Volume Bags July 22, 2015 Reason for the Shortage Baxter states the shortage is due to increased demand. BBraun had 5% dextrose on allocation due to increased demand. Hospira states the shortage is due to increased demand and manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1081 Source Link: http://www.ashp.org Haloperidol Lactate Injection July 22, 2015 Reason for the Shortage Patriot Pharmaceuticals states the reason for the shortage was increased demand. Sagent could not provide a reason for the shortage. Teva has haloperidol lactate on shortage due to manufacturing delays. West-Ward Pharmaceuticals' parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including haloperidol lactate injection. West-Ward is not actively marketing haloperidol lactate at this time. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=527 Copyright© PerformRx, LLC 2015 All Rights Reserved 90 Source Link: http://www.ashp.org Hydroxychloroquine Sulfate Tablets July 22, 2015 Reason for the Shortage Concordia acquired Plaquenil tablets from Covis in April 2015. Ranbaxy has hydroxychloroquine on shortage due to a regulatory issue. Sandoz states the hydroxychloroquine shortage is due to increased demand. Zydus could not provide a reason for hydroxychloroquine shortage. West-Ward discontinued hydroxychloroquine tablets in September 2014. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1126 Source Link: http://www.ashp.org Levetiracetam Injection July 22, 2015 Reason for the Shortage American Regent states the reason for the shortage is manufacturing delay. Caraco cannot provide a reason for the shortage. Fresenius states the reason for the shortage is manufacturing delay. Hospira states the reason for the shortage is increased demand. Sagent states the reason for the shortage is increased demand. X-Gen states the reason for the shortage is change in manufacturing site. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1183 Source Link: http://www.ashp.org Pantoprazole Tablets July 22, 2015 Reason for the Shortage Aurobindo and Teva could not provide a reason for the shortage. Actavis discontinued pantoprazole 20 mg tablets in October 2014. Kremers Urban state the shortage is due to increased demand. Copyright© PerformRx, LLC 2015 All Rights Reserved 91 FDA imposed an import ban in mid-2013 on several Wockhardt products including pantoprazole. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=979 Source Link: http://www.ashp.org Propranolol Injection July 22, 2015 Reason for the Shortage Ben Venue closed its plant in Bedford, Ohio in July 2014. Fresenius Kabi has propranolol injection on back order due to shortage of raw materials. Sandoz cannot provide a reason for the shortage. West-Ward had propranolol injection on shortage due to manufacturing delays. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1091 Source Link: http://www.ashp.org Thrombin Topical Solution (Bovine) July 22, 2015 Reason for the Shortage Pfizer states the reason for the shortage is manufacturing delay. Recombinant thrombin topical solution products (Recothrom) are available and not affected by this shortage. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1199 Source Link: http://www.ashp.org Aminocaproic Acid Oral Presentations July 23, 2015 Reason for the Shortage Akorn acquired Versapharm in 2014. Copyright© PerformRx, LLC 2015 All Rights Reserved 92 Akorn stopped distributing and marketing Versapharm’s aminocaproic acid product on June 22, 2015. Akorn launched Amicar oral solution and 500 mg tablets on June 29, 2015. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1190 Source Link: http://www.ashp.org Benztropine Injection July 23, 2015 Reason for the Shortage American Regent discontinued benztropine injection in May 2015. Fresenius Kabi recalled benztropine injection due to potential for glass particles in the vials. The product is on long-term back order. Nexus divested benztropine injection to Fresenius Kabi in 2012. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1042 Source Link: http://www.ashp.org Diltiazem Injection July 23, 2015 Reason for the Shortage Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Hospira states the reasons for the shortage are manufacturing delays and increases in demand. West-Ward had diltiazem injection on shortage due to manufacturing delays caused by increased demand due to current market conditions. Akorn states the reason for the shortage is increased demand due to market conditions. Teva discontinued all diltiazem presentations in March, 2011. Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=217 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 93 Dipyridamole Injection July 23, 2015 Reason for the Shortage Teva has temporarily discontinued their 2 mL and 10 mL products in order to increase the package sizes. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=465 Source Link: http://www.ashp.org Epinephrine Injection July 23, 2015 Reason for the Shortage American Regent discontinued both epinephrine presentations in early-2015. Amphastar states the shortage is due to increased demand. BPI Labs received FDA approval for epinephrine injection in 2014 and the company launched product in February 2015. Hospira has epinephrine syringes on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=685 Source Link: http://www.ashp.org Ezetimibe and Atorvastatin Tablets July 23, 2015 Reason for the Shortage In January 2014, Merck recalled all Liptruzet lots from wholesalers due to packaging defects in the outer laminate foil pouches. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1084 Source Link: http://www.ashp.org Copyright© PerformRx, LLC 2015 All Rights Reserved 94 Leucovorin Calcium Injection July 23, 2015 Reason for the Shortage Fresenius Kabi has leucovorin on shortage due to increase demand. Teva has leucovorin on allocation due to increased demand. West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired leucovorin calcium injection from Bedford in July 2014. West-Ward is not actively marketing leucovorin calcium injection at this time. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=488 Source Link: http://www.ashp.org Cefepime Injection July 28, 2015 Reason for the Shortage Apotex could not provide a reason for the shortage. Baxter has cefepime on shortage due to increased demand. Fresenius Kabi has cefepime injection on shortage due to manufacturing delays. Sagent has cefepime injection on shortage due to increased demand. Sandoz cannot provide a reason for the shortage. Hospira has Maxipime on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1176 Source Link: http://www.ashp.org Cefazolin Injection July 28, 2015 Reason for the Shortage BBraun has cefazolin on shortage due to increased demand. Fresenius Kabi has cefazolin on shortage due to increased demand. WG Critical Care has cefazolin on shortage due to increased demand. WG Critical Care discontinued cefazolin 20 gram to focus on other strengths. Sandoz has cefazolin on shortage due to manufacturing delays. Hospira has cefazolin on shortage due to increased demand. Copyright© PerformRx, LLC 2015 All Rights Reserved 95 Sagent has cefazolin on shortage due to increased demand. Article Link: http://ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=987 Source Link: http://www.ashp.org * Please refer to ASHP website for more information Copyright© PerformRx, LLC 2015 All Rights Reserved 96 NEW DRUGS COMING TO MARKET PRODUCT Odomzo MFR Novartis ROUTE PO Epiduo Forte (adapalene and benzoyl peroxide) Envarsus XR (tacrolimus extended release) Galderma Labs Rexulti (brexpiprazole) Otsuka Pharmaceu ticals PO Entresto (valsartan/ sacubitril) Novartis PO Orkambi (lumacaftor/ ivacaftor) Vertex Veloxis Pharma Topical PO PO INDICATION PHARMACOLOGY advanced basal cell carcinoma that has recurred following surgery or radiation; or those who are not candidates for surgery or radiation therapy moderate to severe acne vulgaris Hedgehog signaling pathway inhibitor For the prophylaxis of organ rejection in kidney transplant patients who require or desire conversion from a twice-daily tacrolimus product schizophrenia and as add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD) Heart failure Immunosuppressi ve For the treatment of cystic fibrosis in patients 12 Copyright© PerformRx, LLC 2015 All Rights Reserved Retinoid/antiinfective MARKET RELEASE TBD Approval date07/24/2015 09/2015 Approval date07/16/2015 4Q 2015 Approval date07/10/2015 Serotonindopamine activity modulator 08/2015 Angiotensin receptorneprilysin inhibitor (ARNI) Cystic Fibrosis transmembrane conductance regulator (CFTR) 3Q 2015 Approval date07/10/2015 Approval date07/07/2015 3Q 2015 Approval date07/02/2015 97 PRODUCT MFR Tuxarin ER (chlorphenirami ne/codeine) Spriaso Firdapse (amifampridine) Catalyst Pharmaceu ticals ixazomib Takeda ROUTE PO PO PO obeticholic acid Intercept Pharmaceu ticals PO irinotecan liposomal ( MM-398) Merrimack Pharmaceu ticals Liposo mal formula tion INDICATION years and older, who have the F508del mutation Cough and cold PHARMACOLOGY Anti-tussive/ antihistamine For the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) Acetylcholine stimulant For the treatment of relapsed or refractory multiple myeloma, in combination with lenalidomide and dexamethasone primary biliary cirrhosis Proteasome inhibitor For the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabinebased therapy DNA topoisomerase 1 inhibitor Copyright© PerformRx, LLC 2015 All Rights Reserved MARKET RELEASE TBD Approval date07/01/2015 NDA submission date 07/22/2015 (orphan drug designation) NDA submission date 07/14/2015 (orphan drug designation) First-in-class Farnesoid X receptor agonist NDA submission date 06/29/2015 (fast track designation) Priority review granted. PDUFA date 10/25/2015 98
