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Recall Observatory FDA recall evidence

Drug 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

D-031-2013

September 04, 2012

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 63384
Status
Terminated
Classification
Class II
Quantity
96 bottles
Official record key
drug-enforcement:D-031-2013

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: Lot 15087, Exp 08/15

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination