FDAClass IIIJuly 6, 2016

CVS pharmacy Original Strength Acid Controller tablets recall: Impurity Out of Spec

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

Why was CVS pharmacy Original Strength Acid Controller tablets recalled?

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

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?

Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017

Product
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
84,240 bottles
Distribution
Nationwide
Recall date
July 6, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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