Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
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: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC…
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