D-032-2013 Class II Terminated
FDA drug recall D-032-2013 was initiated by Raritan Pharmaceuticals, Inc. on September 4, 2012 and is designated Class II. 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. The recall status is terminated (terminated October 7, 2014). Affected quantity: 17,136 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2012
- Initiation Date
- September 4, 2012
- Termination Date
- October 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,136 bottles
Product Description
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
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.
Distribution Pattern
Nationwide
Code Information
Lots: 16274, Exp 06/15; 16471 Exp 08/15