Glenmark Pharmaceuticals on Saturday said it had issued a voluntary nationwide recall in the US for seven lots of its oral contraceptive Norgestimate and Ethinyl Estradiol tablets due to a packaging error.
The recall is issued by the company's US arm Glenmark Generics Inc for tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, Glenmark Pharma said in a statement. “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.”
As a result of the error, the daily regimen for these oral contraceptives could leave women consumers in the US at risk for unintended pregnancy, the company said. It, however, did not mention the financial implications of the recall exercise.
The tablets are manufactured and packaged by Glenmark Generics Ltd India and distributed by Glenamark Generics only in US. The company said it discovered the error when it received a complaint from a consumer stating she received one blister pack in which the tablets were packaged in reverse order.
