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

FDA recall notice · announced July 1, 2020 · American Health Packaging

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide USA
Lot/code information: Lot #: 189551, Exp 04/30/2021
Quantity: 265 cartons
Status: Terminated
Products in this recall event:
- 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 do (D-1372-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.