Why it was recalled
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Product description
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Lot numbers, UPCs & expiration codes
Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
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-1541-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 11,661 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-1541-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68941
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
- Postal code
- 07054
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1541-2014
- Classification
- Class II
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 11,661 HDPE bottles
- Termination date
- Nov 20, 2015
- Reason for recall
- Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 24, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2014