Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

Recall Number: D-807-2013

Firm: Bayer HealthCare Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20130724

Initiation Date: 20130613

Termination Date: 20140210

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin