Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.
NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Reason Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
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