Glenmark Generics has recalled seven lots of its generic birth control pills Norgestimate and Ethinyl Estradiol, because in some blister packs the weekly tablet orientation is reversed, putting the pills in the wrong order.
The oral contraceptives were distributed nationwide between September 21 and December 30, 2011. The issue was discovered when a consumer told Glenmark that she got a blister pack in which the tablets were packaged in reverse order.
The pill order is reversed because the blister packaging is rotated 180 degrees within the card, which also makes the lot number and expiration date only visible on the outer pouch. Any blister pack in which the lot number and expiration date are not visible is subject to this recall.
Consumers exposed to affected packaging should begin using a non-hormonal form of contraception. Patients who have the affected blister packs should notify their physician and return the recalled pills to the pharmacy.
The lot numbers of recalled Norgestimate and Ethinyl Estradiol tablets (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg) are as follows:
- Lot number 04110101, expiration 7/31/2013
- Lot number 04110106, expiration 7/31/2013
- Lot number 04110107, expiration 7/31/2013
- Lot number 04110114, expiration 8/31/2013
- Lot number 04110124, expiration 8/31/2013
- Lot number 04110129, expiration 8/31/2013
- Lot number 04110134, expiration 9/30/2013
Adverse events related to this recall can be reported to Glenmark Generics at 888-721-7115 (8 a.m. to 5 p.m. Mon-Fri EST) or to the Food and Drug Administration's MedWatch Program.
Glenmark Generics Inc. Announces a Nationwide Recall of Seven (7) Lots of
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215
mg/0.035 mg, 0.25 mg/0.035 mg (Generic) Due to Possibility of Out of
Sequence Tablets [FDA]