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Class III: unlikely to cause harmTerminated

American Health Packaging Nabumetone Tablets Recall

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards)…

American Health Packaging · Columbus, OH

Risk level
Class III
Reported by FDA
Jul 1, 2020
Recall ID
D-1372-2020
Check your lot numberHow we source this data

Summary

American Health Packaging recalled Nabumetone Tablets starting Jun 10, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1372-2020 on Jul 1, 2020. Reason: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. Status: Terminated.

Why it was recalled

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

Product description

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11

Lot numbers, UPCs & expiration codes

Lot #: 189551, Exp 04/30/2021

Where it was sold

Nationwide USA

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-1372-2020
Classification
Class III
Status
Terminated
Recall initiated
Jun 10, 2020
FDA report date
Jul 1, 2020
Quantity
265 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
American Health Packaging

Original FDA data

Every field from FDA enforcement report D-1372-2020, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
85842
Address
2550 John Glenn Ave Ste A
Code information
Lot #: 189551, Exp 04/30/2021
Postal code
43217-1188
Report date
Jul 1, 2020
Product type
Drugs
Recall number
D-1372-2020
Classification
Class III
Recalling firm
American Health Packaging
Product quantity
265 cartons
Termination date
Aug 3, 2022
Reason for recall
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
Distribution pattern
Nationwide USA
Recall initiation date
Jun 10, 2020
Initial firm notification
Letter
Center classification date
Jul 1, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1372-2020, published Jul 1, 2020. 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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