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Recall Observatory FDA recall evidence

Drug product

Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0.

D-027-2013

September 04, 2012

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 63384
Status
Terminated
Classification
Class II
Quantity
7,608 bottles
Official record key
drug-enforcement:D-027-2013

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 586144, Lots 15085, Exp 04/15; 15086, 15087, Exp 08/15

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination