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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
Recall Number D-062-2013
Classification Class II
Code Info Batch No. SG4704, Exp 02/22/2017.
Product Distributed Qty 750 kgs
Reason For Recall Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Event Detail

Event Id 63550
Product Type Drugs
Status Ongoing
Recalling Firm American Enterprises LLC dba Sterling Gelatin
City Prince George
State VA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern NJ