Status
Terminated
Drug Enforcement D-032-2013
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
October 31, 2012
Termination Date
October 7, 2014
Product Information
- Product description
- DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
- Product quantity
- 17,136 bottles
- 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
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- Address
-
8 Joanna Ct, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-032-2013
- Event ID
- 63384
- Recall initiation date
- September 4, 2012
- Center classification date
- October 25, 2012
- Code info
- Lots: 16274, Exp 06/15; 16471 Exp 08/15
- More code info
- —