Sunday, May 09, 2010

Yaz Recall? Yes there was one

Image representing Bayer HealthCare as depicte...Image via CrunchBase

Good work by Jim Edwards:

The FDA did issue a recall for Yaz back in November 2009. 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.

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.

From the FDA site:

1) YAZ (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets- blister packages 24 active and 4 placebo, NDC 50419-405-03. Recall # D-046-2010;

2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets', NDC 0555-9131-767. Recall # D-047-2010
1) Lot 91605A, Exp 12/2013;
2) Lot number 84080A, Exp 12/2011; lot number 84081A, Exp. 12.2011
Recalling Firm: Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ, by letters on November 6, 2009.
Manufacturer: Schering Gmbh Und Co. Produktio, Weimar, Germany. Firm initiated recall is ongoing.
CGMP Deviations: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.
1) 32,856 boxes (3 blister packages/box);
2) 122,208 boxes (3 blister packages/box)


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