FDA recall D-028-2013

Raritan Pharmaceuticals, Inc. · Class II · drug

Product

Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.

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-028-2013