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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		 Letter
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
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