Download Norgestimate-EE Class I Recall Memo

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