RecallDepth
Class III Terminated

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

Company
Bayer Healthcare Pharmaceuticals, Inc.
Recall Initiated
June 13, 2013
Posted
July 24, 2013
Recall Number
D-807-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
194.62 kg
Firm Location
Morristown, NJ, United States

Reason for Recall

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

Distribution

NY, CA

Lot / Code Info

Lot 87100040

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