Why it was recalled
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Product description
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Lot numbers, UPCs & expiration codes
Lot # 1220211M, Exp 02/2019
Where it was sold
U.S.A. Nationwide including 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-0129-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 53,451 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0129-2019, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81326
- Address
- 1090 Horsham Rd
- Code information
- Lot # 1220211M, Exp 02/2019
- Postal code
- 19454-1505
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0129-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 53,451 bottles
- Termination date
- Apr 3, 2019
- Reason for recall
- Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
- Distribution pattern
- U.S.A. Nationwide including Puerto Rico.
- Recall initiation date
- Oct 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2018