Drug product
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
D-062-2013
Product summary
- Event
- Event 63550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 750 kgs
- Official record key
drug-enforcement:D-062-2013
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Code information: Batch No. SG4704, Exp 02/22/2017.
Distribution pattern: NJ
Derived failure modes
-
Microbial contamination
Microbial Contamination