Recalls / Class III
Class IIID-1058-2016
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
- Affected lot / code info
- Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017
Why it was 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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 84,240 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-22
- FDA classified
- 2016-06-30
- Posted by FDA
- 2016-07-06
- Terminated
- 2017-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1058-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.