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Packaging errors on generic oral contraceptives could result in unexpected pregnancy, recall issued

Filed February 29th, 2012 Joshua Sophy

Glenmark Generics Inc. has issued a recall on select oral contraceptives Norgestimate and Ethinyl Estradiol Tablets due to a packaging error which could lead to dosage confusion and result in an unexpected pregnancy.

According to a statement issued by the company, the recall includes Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. Seven Lots are included in the recall (04110101, 04110106, 04110107, 04110114, 04110124, 04110129, and 04110134. The products included in the recall were distributed nationwide to retail pharmacies from Sept. 21 through Dec. 30, 2011.

The drug is dispensed in blister packs and designed to be taken in a specific order through the pack. There are several colors of tablets in the blister pack, each containing a different amount of the Active Ingredient.

The release from Glenmark Generics indicates: “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 received a consumer complaint recently in which she noted that “one blister pack in the which the tablets were packaged in reverse order.

“The correct packaging configuration of this product has 3 pouch packs packaged in a carton and each pouch pack has one blister which contains 28 tablets (seven tablets each of a different strength and inactive tablets) in which the sequence is white to off-white tablets on top row and inactive light green tablets in bottom row,” the company detailed in its statement.

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