Drug product
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.
D-028-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,552 bottles
- Official record key
drug-enforcement:D-028-2013
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: Lot 16470, Exp 08/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination