Yaz Recall was Issued by FDA in November for Certain Lots

Nearly 33,000 boxes of Yaz birth control pills were recalled in November 2009 over poor manufacturing practices at a Bayer plant in Germany. However, because neither the FDA nor Bayer publicized the recall announcement, it appears that virtually nobody knew about it. 

The Yaz recall was recently brought to light in a pharma industry blog post by Jim Edwards on Bnet.com, after notice of the recall was found buried in an FDA enforcement report from November 25, 2009.

The recall involved boxes of Yaz and the generic version, Ocella, which came after a September FDA warning letter issued to Bayer over problems with Yaz manufacturing practices, including poor quality control at the drug maker’s plant in Weimar, Germany. FDA inspectors found “significant deviations” from good manufacturing practices on active pharmaceutical ingredients (API) used to make the birth control pills, and accused the drug maker of hiding results that showed some batches of the drug were outside the company’s specifications.

Yaz is a birth control pill manufactured by Bayer that contains drospirenone, a new “fourth” generation progestin. Drospirenone is only found in Yaz, it’s precursor, Yasmin, and Ocella, a generic version. While Ocella is distributed by Teva Pharmaceuticals, Bayer still manufactures the drosperinone for the pills.

Bayer was accused of using improper “averaging,” by taking out-of-specification (OOS) test results, diluting them with good test results and then reporting the average instead of reporting instances where the quality of the active ingredients deviated outside of the realm of set parameters.

Following the September warning, the FDA specifically asked for the addresses in the U.S. where the out-of-specification Yaz and Ocella pills where shipped. Some lawyers who are investigating potential lawsuits over the birth control pills speculated at the time that a Yaz recall may be issued for the affected lots, but neither the FDA nor Bayer issued any subsequent statements directed to consumers.

The recall affects 32,856 boxes of Yaz and 122,208 boxes of Ocella. Each box contains three blister packages of one month’s supply of the birth control pills. The Yaz tablets have a lot number of 91605A, and an expiration date of 12/2013. The recalled Ocella tablets have the lot numbers 84080A and 84081A with an expiration date of 12/2011.

Bayer already faces more than 1,100 Yaz lawsuit, Yasmin lawsuit and Ocella lawsuit complaints that have been filed throughout the United States on behalf of women who allege that the drug maker failed to adequately research their birth control pill or warn about the risk of serious and potentially life-threatening injuries, such as stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease and other complications.

Critics have pointed to drospirenone as the likely cause of an increased risk of blood clots and other serious health problems with Yaz and Yasmin. Many of the complaints filed against the drug maker allege that a recall of Yaz and Yasmin should have been issued after post-marketing reports suggested that the birth control pills carry a higher risk than some other oral contraceptives