Drug product
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
D-032-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,136 bottles
- Official record key
drug-enforcement:D-032-2013
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: Lots: 16274, Exp 06/15; 16471 Exp 08/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination