Why it was recalled
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Product description
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Lot numbers, UPCs & expiration codes
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
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-0304-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 17, 2014
- FDA report date
- Dec 24, 2014
- Quantity
- 1,118,400 extended release tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-0304-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69506
- Address
- 20 Waterview Blvd., Suite 3
- Code information
- a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
- Postal code
- 07054
- Report date
- Dec 24, 2014
- Product type
- Drugs
- Recall number
- D-0304-2015
- Classification
- Class III
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 1,118,400 extended release tablets
- Termination date
- Aug 13, 2015
- Reason for recall
- Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 18, 2014