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 Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0.
Lot numbers, UPCs & expiration codes
Item 586144, Lots 15085, Exp 04/15; 15086, 15087, Exp 08/15
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-027-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 7,608 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Raritan Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-027-2013, 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
- Item 586144, Lots 15085, Exp 04/15; 15086, 15087, Exp 08/15
- Postal code
- 08816-2108
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-027-2013
- Classification
- Class II
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- Product quantity
- 7,608 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 Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2012
- Initial firm notification
- Center classification date
- Oct 25, 2012