Drug Enforcement D-024-2013

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
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.
Product quantity
2,988 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-024-2013
Event ID
63384
Recall initiation date
September 4, 2012
Center classification date
October 25, 2012
Code info
CIN 3510963; Lots 16273,16274, Exp 06/15
More code info
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