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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62651
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 2012-05-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Kansas and California.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin. Lot Number: 81202450, Exp 06/15/16 Class II Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. 112.295 kg D-1433-2012