Recalls / Class II
Class IID-024-2013
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.
- Affected lot / code info
- CIN 3510963; Lots 16273,16274, Exp 06/15
Why it was recalled
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Recalling firm
- Firm
- Raritan Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 8 Joanna Ct, N/A, East Brunswick, New Jersey 08816-2108
Distribution
- Quantity
- 2,988 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-04
- FDA classified
- 2012-10-25
- Posted by FDA
- 2012-10-31
- Terminated
- 2014-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-024-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.