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.
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Learn MoreYaz 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
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7 Comments
KeelyNovember 30, 2010 at 2:18 am
I know that when I started taking Yaz I was very healthy. I do know my blood clot in my arm is very rare. I t started out a 24in blood clot. I found it when I was with child. I was 8 months along when I thought I had a stroke. I was so frighten. I thought I lost my son. It turns outs my son saved me. If we did not find the clot I could have died. I talk with the doctor and only thing I was taking [Show More]I know that when I started taking Yaz I was very healthy. I do know my blood clot in my arm is very rare. I t started out a 24in blood clot. I found it when I was with child. I was 8 months along when I thought I had a stroke. I was so frighten. I thought I lost my son. It turns outs my son saved me. If we did not find the clot I could have died. I talk with the doctor and only thing I was taking before my son was Yaz. Now two years later I still have a five inch clot. Oh yeah along with nerve damage and out ragous medical bills.
AnnaNovember 9, 2010 at 3:13 am
I have a question!!! If the pills that I got do not have the lot number listed in the article, can I still use them??? I've been on Yaz for 5 yrs I think, and no problems, nothing negative I think...i did get better skin...however, I keep getting yeast infection before my period but all gynos say it cannot be birth control pills.
JenniferSeptember 23, 2010 at 5:20 pm
My daughter (17 yrs.old) was put on YAZ in Jan. 2010 for treatment of menstrual cramps. Within one month she began having excrusiating pain in her stomach, which led to over 10 missed days of school during crucial final exams. Finally, in August after months of unexplained pain, her Dr. recommended a gallbladder ultrasound which showed that her gallbladder was diseased. My daughter was immediatel[Show More]My daughter (17 yrs.old) was put on YAZ in Jan. 2010 for treatment of menstrual cramps. Within one month she began having excrusiating pain in her stomach, which led to over 10 missed days of school during crucial final exams. Finally, in August after months of unexplained pain, her Dr. recommended a gallbladder ultrasound which showed that her gallbladder was diseased. My daughter was immediately scheduled for emergency surgery to have her gallbladder removed. Bayer should be held accountable; I would have NEVER put my child on a drug that had such severe side effects. This has totally disrupted her life; she is a senior taking AP classes and trying to decide on a college. She is missing out on her cross country season and now is behind on her college applications also. I cannot believe that there are ZERO consequences and people are still being prescribed this pill EVERYDAY!!! This pill needs to be recalled ASAP! Do NOT take any form of this terrible pill!
BrianJuly 23, 2010 at 6:40 pm
Yaz killed my wife.She went from being healthy to being on yaz for a year and having gall blatter surgery which resulted in her death.We have 3 small kids.She was put on it for menstral headaches which we were told it would help.Bull shit.bayer and the fda suck
melanieJune 19, 2010 at 11:55 pm
i have to say , everyone is making themselves crazy about yaz, yasmin or ocella. i startet taking yaz when i was 15 years old (which iam german and lived in germany at that time. so all we take over there is almost all maid by bayer)! i took yaz until i was 19 years old (4 years of taking yaz without a stop). i stopped taking yaz because i wanted to become pregnant, which i did 2 weeks after stop[Show More]i have to say , everyone is making themselves crazy about yaz, yasmin or ocella. i startet taking yaz when i was 15 years old (which iam german and lived in germany at that time. so all we take over there is almost all maid by bayer)! i took yaz until i was 19 years old (4 years of taking yaz without a stop). i stopped taking yaz because i wanted to become pregnant, which i did 2 weeks after stopping the pill.now iam back on yasmin for the last 2 years and i have to say, yaz always been good to me,never gotten sick, no horrible side effects and a very healthy son.bayer is taking very good care of there medications because they couldnt effort to close down their company.
JanelMay 11, 2010 at 1:53 am
In Dec 09 I was hospitalized for not one, but three pulmonary embolisms - blood clots in my lungs- caused by Yaz. These pills almost killed me and that is no exaggeration. I will do everything in my power to help warn women that this medication is a risk to your life. I am only so lucky that I still have mine. And my heart goes out to families that have lost a mother, sister, aunt, cousin or frien[Show More]In Dec 09 I was hospitalized for not one, but three pulmonary embolisms - blood clots in my lungs- caused by Yaz. These pills almost killed me and that is no exaggeration. I will do everything in my power to help warn women that this medication is a risk to your life. I am only so lucky that I still have mine. And my heart goes out to families that have lost a mother, sister, aunt, cousin or friend due to the negligence of the Bayer Company and the FDA.
JaimieMay 9, 2010 at 12:07 am
I am a pharmacy technician and I have been taking YAZ for over a year - I have endured some pretty nasty side effects (profuse night sweats, complete loss of menses, and 20lb weight gain). I never really paid attention to the recent television commercials about all of the lawsuits involving Yaz, Yasmin and Ocella until now. Being a professional in the pharmaceutical industry and not having been no[Show More]I am a pharmacy technician and I have been taking YAZ for over a year - I have endured some pretty nasty side effects (profuse night sweats, complete loss of menses, and 20lb weight gain). I never really paid attention to the recent television commercials about all of the lawsuits involving Yaz, Yasmin and Ocella until now. Being a professional in the pharmaceutical industry and not having been notified of such a hazardous problem with this medication, I am truly shocked and unnerved that Bayer Pharmaceuticals did not issue a recall or warning about the problems revolving around the use of this medication. As of today, I have stopped taking Yaz.