FDA recall D-024-2013

Raritan Pharmaceuticals, Inc. · Class II · drug

Product

Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.

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

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-024-2013