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Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves C...

FDA Recall #D-024-2013 — Class II — September 4, 2012

Recall #D-024-2013 Date: September 4, 2012 Classification: Class II Status: Terminated

Product Description

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.

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

2,988 bottles

Distribution

Nationwide

Code Information

CIN 3510963; Lots 16273,16274, Exp 06/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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