FDA recall D-031-2013

Raritan Pharmaceuticals, Inc. · Class II · drug

Product

Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6

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-031-2013