Why it was recalled
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Product description
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Lot numbers, UPCs & expiration codes
Lot: 1037736A, Exp 03/18
Where it was sold
Nationwide and Puerto Rico
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-0014-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 25, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 13,284 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Laboratories, FL, Inc.
Original FDA data
Every field from FDA enforcement report D-0014-2016, exactly as published.
Show all FDA fields
- City
- Davie
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 72308
- Address
- 4955 Orange Dr
- Code information
- Lot: 1037736A, Exp 03/18
- Postal code
- 33314-3902
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0014-2016
- Classification
- Class II
- Recalling firm
- Actavis Laboratories, FL, Inc.
- Product quantity
- 13,284 bottles
- Termination date
- Apr 10, 2017
- Reason for recall
- Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 13, 2015