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
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
Lot numbers, UPCs & expiration codes
Lots: 16274, Exp 06/15; 16471 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-032-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 17,136 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Raritan Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-032-2013, 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: 16274, Exp 06/15; 16471 Exp 08/15
- Postal code
- 08816-2108
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-032-2013
- Classification
- Class II
- Recalling firm
- Raritan Pharmaceuticals, Inc.
- Product quantity
- 17,136 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
- DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 4, 2012
- Initial firm notification
- Center classification date
- Oct 25, 2012