Why it was recalled
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Product description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Lot numbers, UPCs & expiration codes
Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
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-1300-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2014
- FDA report date
- May 14, 2014
- Quantity
- 109,744 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1300-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67933
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
- Postal code
- 07054
- Report date
- May 14, 2014
- Product type
- Drugs
- Recall number
- D-1300-2014
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 109,744 bottles
- Termination date
- May 12, 2015
- Reason for recall
- Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 1, 2014
- Initial firm notification
- Letter
- Center classification date
- May 2, 2014