FDA Drug Recalls

Recalls / Class II

Class IID-031-2013

Product

Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6

Affected lot / code info
Lot 15087, Exp 08/15

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
96 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-031-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls