Key Takeaway

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 by Dr. Reddy's Laboratories, Inc. was recalled on April 22, 2016. The hazard: Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability...

FDA Drug Class III Terminated

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

Recalled: April 22, 2016 ~84,240 bottles units affected D-1058-2016

Description

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

Hazard / Reason

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.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ, United States

View all 163 recalls by Dr. Reddy's Laboratories, Inc. →

Distribution

Nationwide

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