Drug product
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
D-030-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,440 bottles
- Official record key
drug-enforcement:D-030-2013
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