PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 1, 2020 Initiated: June 10, 2020 #D-1372-2020

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

Reason for Recall

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

Details

Recalling Firm
American Health Packaging
Units Affected
265 cartons
Distribution
Nationwide USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Health Packaging. Units affected: 265 cartons.
Why was this product recalled?
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 1, 2020. Severity: Low. Recall number: D-1372-2020.