Drug Enforcement D-027-2013

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Status

Terminated

Classification

Class II

Report Date

October 31, 2012

Termination Date

October 7, 2014

Product Information

Product description
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.
Product quantity
7,608 bottles
Reason for recall
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Raritan Pharmaceuticals, Inc.
Address
8 Joanna Ct, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-027-2013
Event ID
63384
Recall initiation date
September 4, 2012
Center classification date
October 25, 2012
Code info
Item 586144, Lots 15085, Exp 04/15; 15086, 15087, Exp 08/15
More code info
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