Drug product
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.
D-024-2013
Product summary
- Event
- Event 63384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,988 bottles
- Official record key
drug-enforcement:D-024-2013
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: CIN 3510963; Lots 16273,16274, Exp 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination