Recalls / Class II
Class IID-029-2013
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.
- Affected lot / code info
- Lots 16273, Exp 06/15; 16460, 16464, 16466, 16468, 16469, Exp 07/15
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
- 46,104 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-029-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.