Why it was recalled
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Product description
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
Lot numbers, UPCs & expiration codes
Lot #: LN11423, Expiry: 8/15/15
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-1355-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 10, 2014
- FDA report date
- Jun 4, 2014
- Quantity
- 8712 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1355-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68402
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- Lot #: LN11423, Expiry: 8/15/15
- Postal code
- 07054
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1355-2014
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 8712 Bottles
- Termination date
- Aug 13, 2015
- Reason for recall
- Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 10, 2014
- Initial firm notification
- Letter
- Center classification date
- May 29, 2014