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Glenmark Generics recalls seven lots of Norgestimate and Ethinyl Estradiol tablets

25 Feb 2012 Evaluate

Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has issued a voluntary, nationwide, consumer-level recall of seven 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. The recall is being implemented because of a packaging error, where select blisters 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. 

Any blister for which the lot number and expiry date is not visible is subject to recall. This packaging error is limited to the seven 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.

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. These tablets were manufactured and packaged by Glenmark Generics India and are distributed by Glenmark Generics Incorporation, USA. 

Glenmark Generics Incorporation (GGI), USA is the North American division of Glenmark Generics dedicated to the manufacture, marketing and distribution of generic pharmaceutical products. GGI (formerly Glenmark Pharmaceuticals Incorporation, USA) established operations in 2003 and was a subsidiary of Glenmark Pharmaceuticals.

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