Status
Terminated
Drug Enforcement D-028-2013
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
- Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
- Product quantity
- 3,552 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-028-2013
- 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
- —