FDA recall D-030-2013

Raritan Pharmaceuticals, Inc. · Class II · drug

Product

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

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-09-04
Report date: 2012-10-31
Termination date: 2014-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-030-2013