Glenmark Generics Inc issued a voluntary recall in the US of seven lots of oral contraceptive drug Norgestimate and Ethinyl Estradiol tablets in different strengths.
The recall is because of a packaging error in select blisters that resulted in reversing the weekly tablet orientation, making the lot number and expiry date visible only on the outer pouch, Glenmark said. The action, with the knowledge of the Food and Drug Administrator, was following a consumer complaint.
Any blister for which the lot number and expiry date was not visible is subject to recall. This packaging error is limited to the seven lots, the company added.
However, 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 Ltd India and distributed by Glenmark Generics Inc US. This product is distributed to wholesalers and retail pharmacies in the US between September 21, 2011 and December 30, 2011, the company said. Though small in scale, no financial details were given by the company on the impact of the recall.