DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceut...

FDA Recall #D-032-2013 — Class II — September 4, 2012

Recall #D-032-2013 Date: September 4, 2012 Classification: Class II Status: Terminated

Product Description

DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.

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.

Recalling Firm

Raritan Pharmaceuticals, Inc. — East Brunswick, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

17,136 bottles

Distribution

Nationwide

Code Information

Lots: 16274, Exp 06/15; 16471 Exp 08/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated