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.
Product 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
Lot numbers, UPCs & expiration codes
Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1058-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 22, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 84,240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1058-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74220
- Address
- 107 College Rd E
- Code information
- Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017
- Postal code
- 08540-6623
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1058-2016
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 84,240 bottles
- Termination date
- Apr 26, 2017
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2016