Product: 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
Reason for recall: Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Recall initiated: 20130613
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated