FDA Drug Recalls

Recalls / Class II

Class IID-021-2013

Product

Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3

Affected lot / code info
Lot 16273, 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
E-Mail
Type
Voluntary: Firm initiated
Address
8 Joanna Ct, N/A, East Brunswick, New Jersey 08816-2108

Distribution

Quantity
2160 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-021-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.