Glenmark recalls 7 lots of oral contraceptives in US

February 26th, 2012 - 1:11 am ICT by IANS  

Mumbai, Feb 25 (IANS) Glenmark Pharmaceuticals Saturday said it has issued a voluntary nation-wide recall of seven lots of its oral contraceptives — Norgestimate and Ethinyl Estradiol tablets — in the US because of a packaging error.

“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,” the company said in a regulatory filing.

“Any blister for which the lot number and expiry date is not visible is subject to recall,” it added.

The company further said that due to 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.

However it clarified that it would not pose any immediate health risks.

The tablets were manufactured and packaged by Glenmark Generics Ltd India and are distributed by Glenmark Generics Inc USA.

The issue was raised when Glenmark received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order.

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