Drug 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

D-1058-2016

April 22, 2016

Class III

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 74220
Status: Terminated
Classification: Class III
Quantity: 84,240 bottles
Official record key: drug-enforcement:D-1058-2016

Official wording

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.

Code information: Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

out of specification