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Recall Observatory FDA recall evidence

Drug product

CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9

D-022-2013

September 04, 2012

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 63384
Status
Terminated
Classification
Class II
Quantity
16,848 bottles
Official record key
drug-enforcement:D-022-2013

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: Lots 16273, 16274, Exp 06/15; 16463, Exp 07/15

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination