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Recall Observatory FDA recall evidence

Drug product

Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.

D-023-2013

September 04, 2012

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 63384
Status
Terminated
Classification
Class II
Quantity
183,141 bottles
Official record key
drug-enforcement:D-023-2013

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: Item Number: 4091097; Lots 15952, 16271, 16274, 16425, Exp 06/15; 16434, 16435, 16436, 16459, 16461, 16462,16465, Exp 07/15

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination