Drug product
Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.
D-023-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 183,141 bottles
- Official record key
drug-enforcement:D-023-2013
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: Item Number: 4091097; Lots 15952, 16271, 16274, 16425, Exp 06/15; 16434, 16435, 16436, 16459, 16461, 16462,16465, Exp 07/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination