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Recall Observatory FDA recall evidence

Drug product

Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4

D-026-2013

September 04, 2012

Class II

Product summary

Firm
Raritan Pharmaceuticals, Inc.
Event
Event 63384
Status
Terminated
Classification
Class II
Quantity
56,808 bottles
Official record key
drug-enforcement:D-026-2013

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 a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination