D-030-2013 Class II Terminated
FDA drug recall D-030-2013 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: 1,440 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
- 1,440 bottles
Product Description
Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2
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
Lot 16470, Exp 08/15