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Did You Know the FDA Recalled Bayer's Yaz Contraceptive? Neither Did Anyone Else

Bayer (BAY) is being sued in 1,100 lawsuits alleging its best-selling product, the contraceptive Yaz, carries a higher risk of blood clots, so you'd think that when the pill was recalled, it might have generated some headlines. But it didn't.

In fact, the FDA did issue a recall for Yaz back in November 2009 (scroll about halfway down to see it). The reason: Bayer had reported the product was "within specification" when in fact it wasn't -- the company had taken a number of measures and averaged them together to get the number it needed. And no one noticed.

The reason you don't know anything about this is because the recall was buried in an "Enforcement Report" section of the FDA's website. The recall was never published in the "Recalls, Market Withdrawls, & Safety Alerts" section of the site, which is where you'd expect to see such a thing. (The FDA's site is infamously confusing.)

The recall is significant for a number of reasons: First, it involved specifications for the dosage of drospirenone in the pill, which is the new ingredient that the lawsuits allege is more dangerous than the traditional recipe.

Second, the recall wasn't small. It involved 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product.

Third, and perhaps most significant, although the recall was dated Nov. 25, the FDA inspected Bayer on this same issue in March 2009 -- and warned the company about its averaging practice in August 2009. The unanswered question here is, How many out-of-spec pills did women take before the product was recalled?

Even the lawyers suing Bayer had no idea the recall happened, attorney Janet G. Abaray told BNET, and they were looking for just such an event.


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