An article released back in May 2010 on the CBS Business Network web site reported on a Yaz recall ordered by the FDA in November of 2009. The recall was reported on the FDA’s enforcement report page of its web site. The FDA neglected to publish news of the recall on its “Recalls, Market Withdrawals, & Safety Alerts” web page.
The recall was for over 30,000 boxes of Yaz and over 120,000 boxes of Ocella, a generic Yaz twin. The FDA cited the reasoning behind the recall as, “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.” In other words, Bayer deliberately skewed lab results in order to hide the fact that the amount of drospirenone was inconsistent.
Drospirenone has drawn fire in a British Medical Journal study and from over 4000 plaintiffs who have filed lawsuits against Bayer over the Yaz, Yasmin, and Ocella ingredient. The CBS article reported, “Even the lawyers suing Bayer had no idea the recall happened.” The article also noted that the FDA had previously inspected Bayer lab results and warned them about skewing the results in March of 2009seven months before recalling the suspect products.
Hundreds of thousands of women could have taken skewed doses of drospirenone during those seven months. Bayer continues to sell Yaz, Yasmin, Ocella, and Beyaz, even while the lawsuits proceed. The FDA has not issued recalls or initiated investigations into Bayer. In fact, the Administration approved the sale of Beyaz in September 2010. Apparently they have forgiven Bayer for deliberately masking lab results a year earlier on products that never should have been sold in the first place.
Edwards, Jim. (May 6, 2010) “Did You Know the FDA Recalled Bayer’s Yaz Contraceptive? Neither Did Anyone Else.” Retrieved on October 21, 2010 from the CBS Business Network.
FDA Staff. (November 25, 2009) “Enforcement Report for November 25, 2009.” Retrieved on October 21, 2010 from the FDA web site.