Status
Terminated
Drug Enforcement D-062-2013
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Classification
Class II
Report Date
November 28, 2012
Termination Date
November 28, 2012
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- NJ
Location & Firm
- Recalling firm
- American Enterprises LLC dba Sterling Gelatin
- Address
-
4595 Sandesara Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-062-2013
- Event ID
- 63550
- Recall initiation date
- September 21, 2012
- Center classification date
- November 21, 2012
- Code info
- Batch No. SG4704, Exp 02/22/2017.
- More code info
- —