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Class II: temporary or reversible health riskTerminated

Wockhardt Metoprolol Succinate Extended-Release Tablets Recall

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Ma…

Wockhardt Usa Inc. · Parsippany, NJ

Risk level
Class II
Reported by FDA
May 14, 2014
Recall ID
D-1300-2014
Check your lot numberHow we source this data

Summary

Wockhardt recalled Metoprolol Succinate Extended-Release Tablets starting Apr 1, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1300-2014 on May 14, 2014. Reason: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1300-2014, published May 14, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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