Recalls / Class II
Class IID-025-2013
Product
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
- Affected lot / code info
- Item 119160TGT; Lots15952, Exp 06/15; 16459, 16460, 16463, Exp 07/15; 16475, Exp 08/15
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
- 48,120 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-025-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.