Status
Terminated
Drug Enforcement D-030-2013
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
- Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2
- Product quantity
- 1,440 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-030-2013
- Event ID
- 63384
- Recall initiation date
- September 4, 2012
- Center classification date
- October 25, 2012
- Code info
- Lot 16470, Exp 08/15
- More code info
- —