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INTEROFFICE MEMORANDUM To: MAPMG Physicians, Nurse Practitioners, Physician Assistants, Pharmacy Staff Subject: Class I DRUG RECALL: Generic Norgestimate and Ethinyl Estradiol Tablets (NDC# 68462-565-29) Date: March 8, 2012 From: Sheireen Huang, PharmD, Manager, Clinical Pharmacy Services Carol Forster, MD Director, Pharmacy and Therapeutics/Medication Safety Situation: On February 24, 2012, Glenmark Generics issued a voluntary nationwide recall of 7 lots of generic norgestimate and ethinyl estradiol tablets; On February 28th, Kaiser Permanente initiated a Class I recall of the affected lots. Background: Norgestimate/Ethinyl estradiol (generic Tri-Sprintec, Ortho Tri-Cyclen, Tri-Nessa, and Tri-Previfem) is a triphasic oral contraceptive containing 7 tablets of 0.18 mg norgestimate /0.035 mg ethinyl estradiol, 7 tablets of 0.215 mg norgestimate /0.035 mg ethinyl estradiol, and 7 tablets of 0.25 mg norgestimate /0.035 mg ethinyl estradiol in a blister pack. Glenmark Generics issued of the recall due to a packaging error which resulted in the reversal of the weekly tablet orientation and making the lot number and expiration date only visible on the outer pouch. As a result of this packaging error, patients taking these medications for oral contraception may be at risk for unintended pregnancies. Norgestimate and Ethinyl Estradiol Tablets Affected Lot Numbers Lot Number Expiration Date Distribution Date 04110101 07/2013 04110106 07/2013 Manufacturer distributed affected 04110107 07/2013 products between September 21, 2011 04110114 08/2013 and December 30, 2011 04110124 08/2013 04110129 08/2013 04110134 09/2013 Given the potential for safety issues if affected lots are administered to patients, Kaiser Permanente initiated Class I recall procedures program-wide. An analysis of prescription data between October 28, 2011 and February 29, 2012 indicates that 3 patients may have received an affected product from an external or network pharmacy. Previous purchase history shows that KPMAS pharmacies have no purchases of generic norgestimate and ethinyl estradiol tablets since January 2010. Assessment: Kaiser Permanente has initiated a Class I recall for 7 lots of generic norgestimate and ethinyl estradiol tablets due to a packaging error which may increase the risk of an unintended pregnancy in patients using the medication for oral contraception. Potentially affected patients and their prescribing providers will be notified of this recall and provided direction on further actions. Recommendations/Action Requested: If patients believe they have an affected product they should be counseled to use an effective method of back-up contraception and contact the dispensing pharmacy. Thank you for your attention to this recall notice. March 2012 Confidential – For internal use only