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.
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
Lot numbers, UPCs & expiration codes
Lots a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-026-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 56,808 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Raritan Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-026-2013, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63384
- Address
- 8 Joanna Ct
- Code information
- Lots a) 15952, 16270,16425, Exp 06/15; b)16459, 16466, 16467, Exp 07/15
- Postal code
- 08816-2108
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-026-2013
- Classification
- Class II
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- Product quantity
- 56,808 bottles
- Termination date
- Oct 7, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2012
- Initial firm notification
- Center classification date
- Oct 25, 2012