Thousands of Boxes of Yaz Recalled Last November, Few Knew

July 19, 2010, 10:30AM. By Gordon Gibb

Washington, DCWith more than 1,000 lawsuits percolating through the courts alleging that Yasmin and Yaz birth control caused blood clots and other adverse reactions, comes the news that a sizeable lot of Yaz birth control pills was recalled by the US Food and Drug Administration (FDA) in November of last year.

Jim Edwards, writing on BNET (CBS Business Network), noted in May that Bayer recalled nearly 33,000 boxes of Yaz birth control, with three blister packages in each box, due to a discrepancy relating to a specification and a deviation from good manufacturing practices.

According to the 11/25/09 FDA alert, "Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification."

Yaz manufacturer Bayer had allegedly reported to the FDA that Yaz was within specifications when, in the FDA's view, it was not. Edwards reports that the FDA had actually called Bayer on that same point the previous March, following up with a warning about its averaging practice in August.

The boxes were finally recalled in November.

Edwards wonders how many women might have taken Yaz not within specification before the products were recalled—a significant question considering the risks for blood clot associated with drospirenone, the ingredient alleged by lawsuits to be more dangerous than that found in older-generation contraceptives.

The other question has to do with why the Yaz recall was not published in the "Recalls, Market Withdrawals and Safety Alerts" section of the official FDA website, but rather was buried in the middle of an Enforcement Report, unseen and unreported.

According to the FDA enforcement document, the recalled product was Yaz (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets - blister packages 24 active and 4 placebo, NDC 50419-405-03. Recall # D-046-2010; Lot 91605A, with an expiry of December 2013.

The total number of boxes recalled was 32,856.