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 |
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