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Class III: unlikely to cause harmTerminated

Teva Pharmaceuticals NABUMETONE Tablets Recall

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd

Teva Pharmaceuticals USA · North Wales, PA

Risk level
Class III
Reported by FDA
Mar 23, 2016
Recall ID
D-0773-2016
Check your lot numberHow we source this data

Summary

Teva Pharmaceuticals recalled NABUMETONE Tablets starting Nov 19, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0773-2016 on Mar 23, 2016. Reason: Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Status: Terminated.

Why it was recalled

Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.

Product description

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

Lot numbers, UPCs & expiration codes

Lot #: 05N533, Exp 11/16

Where it was sold

Nationwide and Puerto Rico.

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-0773-2016
Classification
Class III
Status
Terminated
Recall initiated
Nov 19, 2015
FDA report date
Mar 23, 2016
Quantity
576 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0773-2016, exactly as published.

Show all FDA fields
City
North Wales
State
PA
Status
Terminated
Country
United States
Event ID
72999
Address
1090 Horsham Rd
Code information
Lot #: 05N533, Exp 11/16
Postal code
19454-1505
Report date
Mar 23, 2016
Product type
Drugs
Recall number
D-0773-2016
Classification
Class III
Recalling firm
Teva Pharmaceuticals USA
Product quantity
576 bottles
Termination date
Nov 15, 2016
Reason for recall
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Distribution pattern
Nationwide and Puerto Rico.
Recall initiation date
Nov 19, 2015
Initial firm notification
Letter
Center classification date
Mar 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0773-2016, published Mar 23, 2016. 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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