Download Provider Memo - Kaiser Permanente

INTEROFFICE MEMORANDUM
To:
MAPMG Providers, Nurse Practitioners,
Physician Assistants, Pharmacy Staff
Date:
September 11, 2015
Subject:
CLASS II DRUG RECALL:
From:
Sheireen Huang, Pharm.D.
Manager, Clinical Pharmacy Services
and
Carol Forster, MD
Physician Director, Pharmacy and
Therapeutics/Medication Safety
Refresh Lacri-Lube and Refresh P.M.
Ophthalmic Ointments
Manufactured by Allergan
Situation:
A Class II recall has been issued for Refresh Lacri-Lube and Refresh P.M ophthalmic ointments, manufactured
by Allergan, due to particulate matter.
Backgound:
Refresh Lacri-Lube and Refresh P.M are over-the-counter (OTC) eye lubricants used as a protectant against
further irritation or for temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure
to wind or sun.
To date, Allergan has received reports of small black particles which were found to be part of the cap and
created when unscrewing the cap from the aluminum tube.
Adverse events related to this recall reported to Allergan include: foreign body in the eye, eye irritation, ocular
discomfort, product contamination, superficial injury of the eye, eye pain, eye swelling, and blurred vision.
The products and lots listed in the table below are recalled:
Product
NDC:
LOT / EXP:
Refresh Lacri-Lube in 3.5 g
00023-0312-04
84746 – 04/30/2017 86045 – 08/31/2017
tubes
84987 – 05/31/2017 86406 – 09/30/2017
85087 – 05/31/2017 86594 – 10/31/2017
85359 – 06/30/2017 87021 – 11/31/2017
85721 – 07/31/2017
Refresh Lacri-Lube in 7 g tubes 00023-0312-07
86470 – 09/30/2017 87105 – 11/30/2017
86829 – 10/31/2017
Refresh P.M. in 3.5 g tubes
00023-0240-04
85165 – 05/31/2017 86506 – 09/30/2017
85228 – 05/31/2017 86515 – 09/30/2017
85244 – 06/30/2017 86517 – 09/30/2017
85351 – 06/30/2017 86746 – 10/31/2017
85374 – 06/30/2017 86792 – 10/31/2017
85397 – 06/30/2017 86789 – 10/31/2017
85561 – 07/31/2017 86809 – 10/31/2017
85676 – 07/31/2017 86822 – 10/31/2017
85694 – 07/31/2017 86822A – 10/31/2017
85834 – 08/31/2017 86932 – 11/30/2017
85977 – 08/31/2017 87100 – 11/30/2017
85985 – 08/31/2017 87068 – 11/30/2017
86073 – 08/31/2017 87156 – 12/31/2017
85599 – 09/30/2017 87261 – 12/31/2017
86290 – 09/30/2017 87493 – 01/31/2018
86325 – 09/30/2017 87494 – 02/28/2018
86411 – 09/30/2017 87731 – 02/28/2018
86427 – 09/30/2017
Refresh P.M. in 3.5 g tubes
00023-0240-04
85165 – 03/31/2017 86789 – 10/31/2017
(professional sample pack)
CLASS II DRUG RECALL:
Refresh Lacri-Lube and Refresh P.M. Ophthalmic Ointments
A Class II recall is a situation where the use of, or exposure to, a violative product may cause temporary or
medically reversible adverse health consequences or where the probability of serious adverse consequences is
remote and requires immediate removal of product from shelves.
KPMAS pharmacies have purchases of the recalled OTC products.
Assessment:
KPMAS pharmacies were notified of this Class II recall on Wednesday, August 26, 2015. All shelves were
checked for product.
Recommendations:
1. Providers and pharmacy staff should be aware of this recall due to the potential patient safety
implications.
2. Communication will be available for providers and posted on the KPMAS pharmacy website (PIT-HELP)
and the Community Provider Portal (CPP) for affiliated providers.
3. A sign shall be developed and posted on OTC shelves near the product to alert patients to the recall. The
sign shall encourage patients to contact Allergan to determine if they have one of the recalled lots and if
needed, arrange for replacement.
Thank you for your attention to this recall notice.
References:
1. Refresh Lacri-Lube, Daily Med. Accessed 8/26/15. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d232a44b-516d-
4cdf-a4e7-c3a9a50dc7af
2. Refresh P.M., Daily Med. Accessed 8/26/15. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24365d64-cd94-41cc-
a7e1-033102d98114
3. Recall Press Release: Allergan Issues Voluntary Nationwide Recall in the U.S. of Specific Lots of Refresh Lacri-Lube, Refresh
P.M., FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate
ophthalmic ointment, USP) 10%/0.2% for Particulate Matter. Accessed 8/26/15.
http://www.fda.gov/Safety/Recalls/ucm459485.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
4. KPMAS Pharmacy Distribution Center Class II Recall Notification (sent 8/26/15).
KPMAS Pharmacy Services, September 2015