FDAClass IIOctober 31, 2012

Leader Fiber Capsules recall: Sterility Concern

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.

Why was Leader Fiber Capsules recalled?

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Raritan Pharmaceuticals, Inc.
Quantity
2,988 bottles
Distribution
Nationwide
Recall date
October 31, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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