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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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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
Distribution Pattern NY, CA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot 87100040 Class III Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. 194.62 kg D-807-2013