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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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
Classification Class III
Code Info Lot 87100040
Product Distributed Qty 194.62 kg
Reason For Recall Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Event Detail

Event Id 65702
Product Type Drugs
Status Ongoing
Recalling Firm Bayer HealthCare Pharmaceuticals Inc.
City Wayne
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern NY, CA