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Generic Yasmin Recall Issued Due to Pregnancy Risk From Incorrect Packaging of Birth Control Pills

Manufacturing problems may have caused certain packs of generic Yasmin birth control pills to be distributed with some missing or incorrectly arranged tablets, which may leave women unprotected against becoming pregnant. 

The FDA announced a generic Yasmin recall on March 4, impacting four lots of Apotex Corp. Drospirenone and Ethinyl Estriadol Tablets, which may have placebo pills in the wrong area, or missing tablets.

The recalled birth control pill packs may contain defective blisters, with incorrect tablet arrangements. They may also have an empty blister pocket.

If a woman receives a pack with missing tablets, or with tablets in the wrong arrangements, they may take pills in the wrong order, lowering their effectiveness at preventing pregnancy.

To date, there have been no cases of unintended pregnancy reported in connection to the drospirenone and ethinyl estradiol birth control tablet recall. FDA officials warn women should not stop taking the birth control pills. However, they should use a non-hormonal method of birth control, in addition to taking the pills.

The product consists of 28 film-coated, biconvex tablets in the following order, 21 yellow color tablets containing 3 mg of drospirenone and 0.03 mg ethanol estradiol followed by seven placebo white color tablets.

The recall affects packs of tablets with lot numbers 7DY008A,7DY009A, 7DY010A, and 7DY011A with NDC number 60505-4183-3 on the outer carton.

The pills were manufactured by Oman Pharmaceutical Products, Co. LLC. and distributed by Apotex Corp.

In prior years, the original manufacturer of name-brand Yasmin, Bayer, faced a number of product liability lawsuits over health risks linked to the birth control pills, including blood clots, heart attacks and strokes. Most of those lawsuits were settled or otherwise resolved.

Apotex is currently arranging for a recall of all affected products from wholesalers, distributors and retailers. Those customers have been asked to quarantine the recalled lots immediately if found in their inventory.

Consumers with affected birth control pills have been asked to return the affected pills to the pharmacy where they purchased them. However, customers who purchased recalled pills directly from Apotex can call GENCO at 1-877-674-2082. Consumers with questions can call Apotex Corp. at 1-800-706-5575.

Adverse reactions related to this product should be reported to the FDA’s MedWatch Adverse Event reporting program.

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