Recalls / Class II
Class IID-026-2013
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
- Affected lot / code info
- Lots a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15
Why it was recalled
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Recalling firm
- Firm
- Raritan Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 8 Joanna Ct, N/A, East Brunswick, New Jersey 08816-2108
Distribution
- Quantity
- 56,808 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-04
- FDA classified
- 2012-10-25
- Posted by FDA
- 2012-10-31
- Terminated
- 2014-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-026-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.