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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description 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.
Recall Number D-1433-2012
Classification Class II
Code Info Lot Number: 81202450, Exp 06/15/16
Product Distributed Qty 112.295 kg
Reason For Recall Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.

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.