Glenmark Generics Inc. announced a voluntary recall of seven lots of norgestimate and ethinyl estradiol birth control tablets.
In a news release, the Food and Drug Administration said the recall was issued after a packaging error was discovered, 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 agency said the product is used as an oral contraceptive for the prevention of pregnancy in women, and as a result of the packaging error, the daily regimen for the oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Glenmark Generics said the defects do not pose any immediate health risks. However, consumers exposed to the affected packaging should begin using a nonhormonal form of contraception immediately.
The affected tablets were distributed to wholesalers and retail pharmacies nationwide from Sept. 21, 2011 to Dec. 30, 2011.
The recalled lot numbers include: 04110101, 04110106, 04110107, 04110124, 04110129 and 04110134, 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).
Patients who have the affected product should notify their physician and return the product to the pharmacy. Any adverse events that may be related to the use of the recalled products should be reported to Glenmark Generics at 888-721-7115.