Birth Control Recall-Yaz and Yasmin

The FDA released a warning letter this week sent to Bayer Pharmaceuticals over Yaz and Yasmin problems at the drug makers manufacturing plant in Germany. The letter indicates that Bayer hid out-of-specification test results for key ingredients in the birth control pills and said that several batches of the drugs should have never been released to the public. In what could be a forerunner to a Yasmin and Yaz recall, the FDA has asked for detailed lists of the batches shipped to U.S. customers.

Yaz and Yasmin are two popular birth control pills manufactured by Bayer that combine the active pharmaceutical ingredient drospirenone with ethinyl estradiol to prevent pregnancy. According to the FDA letter sent to the drug giant, several problems with the manufacturing process were identified at a plant in Germany where drospirenone was produced.
Instead of identifying batches of drugs that may be bad and preventing them from being released to the public, the FDA indicates Bayer took the results of these out-of-compliance drugs and hid them by averaging the numbers with good results. The FDA indicates that this is an “unacceptable practice” and stressed that each of the results should be treated independently.