Drug product
Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9.
D-029-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46,104 bottles
- Official record key
drug-enforcement:D-029-2013
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: Lots 16273, Exp 06/15; 16460, 16464, 16466, 16468, 16469, Exp 07/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination