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Recall Observatory FDA recall evidence

Drug 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

D-1372-2020

June 10, 2020

Class III

Product summary

Firm
American Health Packaging
Event
Event 85842
Status
Terminated
Classification
Class III
Quantity
265 cartons
Official record key
drug-enforcement:D-1372-2020

Official wording

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

Code information: Lot #: 189551, Exp 04/30/2021

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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