Status
Terminated
Drug Enforcement D-026-2013
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Classification
Class II
Report Date
October 31, 2012
Termination Date
October 7, 2014
Product Information
- Product description
- 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
- Product quantity
- 56,808 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
- 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-026-2013
- Event ID
- 63384
- Recall initiation date
- September 4, 2012
- Center classification date
- October 25, 2012
- Code info
- Lots a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15
- More code info
- —