Drug Manufacturer Recalls Birth Control Pills

The U.S. Food and Drug Administration on Monday announced that Glenmark Generics Inc. USA has issued a voluntary, nationwide, consumer-level recall of seven (7) lots of the oral contraceptive 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.

The product, which is a generic version of Ortho Tri-Cyclen, 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.

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 (7) lots listed in the table below 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).

These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately, the FDA said. People who have the recalled product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.

This product was distributed to wholesalers and retail pharmacies nationwide between Sept. 21, 2011 and Dec. 30, 2011. This product is distributed by Glenmark Generics Inc. only in the U.S.

Lot numbers of affected packs 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), are as follows:

NDC : 68462-565-29

Lot No. 04110106 (exp. 07/31/2013)

Lot No. 04110107 (exp. 07/31/2013)

Lot No. 04110114 (exp. 08/31/2013)

Lot No. 04110124 (exp. 08/31/2013)

Lot No. 04110129 (exp. 08/31/2013)

Lot No. 04110134 (exp. 09/30/2013)