Glenmark Generics Inc. recently announced a recall of seven lots of Norgestimate and Ethinyl Estradiol Tablets (birth control) USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. The recall is being implemented because of a packaging error, where select blister packs were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. This packaging error is limited to the seven (7) lots listed in the table below 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.
This product is used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.
These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011.
Lot numbers of affected packs 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), are as follows:
According to the recall notice, any adverse events that may be related to the use of these products should be reported to Glenmark Generics Inc., USA at 1-(888)721-7115 (8 AM to 5 PM Mon-Fri EST) .
If you have experienced an unintended pregnancy due to mislabeled or incorrectly dosed birth control, a defective products attorney may be able to help you pursue the compensation you deserve. For more information, call 1-888-BURNETTI.