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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals Metoprolol Succinate Extended-release Tablets Recall

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mf…

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
Oct 15, 2014
Recall ID
D-0009-2015
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Metoprolol Succinate Extended-release Tablets starting Jul 3, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0009-2015 on Oct 15, 2014. Reason: Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Product description

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

Lot numbers, UPCs & expiration codes

Lot 3023805 Exp. 11/15

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-0009-2015
Classification
Class II
Status
Terminated
Recall initiated
Jul 3, 2014
FDA report date
Oct 15, 2014
Quantity
15,966 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0009-2015, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
68783
Address
781 Chestnut Ridge Rd
Code information
Lot 3023805 Exp. 11/15
Postal code
26505-2730
Report date
Oct 15, 2014
Product type
Drugs
Recall number
D-0009-2015
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
15,966 bottles
Termination date
Sep 20, 2016
Reason for recall
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Voluntary / mandated
Voluntary: Firm initiated
Product description
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
Distribution pattern
Nationwide
Recall initiation date
Jul 3, 2014
Initial firm notification
E-Mail
Center classification date
Oct 8, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0009-2015, published Oct 15, 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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