American Health Packaging recalls Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Ameri…

Recall date

June 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1372-2020

FDA classification

Class III

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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