FDAClass IIOctober 31, 2012

DRxChoice Fiber Capsules recall: Sterility Concern

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

Why was DRxChoice 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?

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

Product
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
Recalling firm
Raritan Pharmaceuticals, Inc.
Quantity
17,136 bottles
Distribution
Nationwide
Recall date
October 31, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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