Drug Enforcement D-025-2013

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
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
Product quantity
48,120 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-025-2013
Event ID
63384
Recall initiation date
September 4, 2012
Center classification date
October 25, 2012
Code info
Item 119160TGT; Lots15952, Exp 06/15; 16459, 16460, 16463, Exp 07/15; 16475, Exp 08/15
More code info
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