American Health Packaging has issued a voluntary recall for 265 cartons of Nabumetone Tablets, USP, 500 mg, a prescription nonsteroidal anti-inflammatory drug (NSAID). The recall was initiated because the carton labels were missing the required instruction for pharmacists to dispense the medication with an accompanying Medication Guide. These guides contain critical safety information for patients regarding the risks and proper use of the medication. The affected products were distributed nationwide in the United States and were packaged in cartons containing 100 tablets (10 blister cards of 10 tablets each).
Without the required labeling instruction, a pharmacist may fail to provide the Medication Guide to the patient, which could result in the patient being unaware of serious potential side effects or safety warnings associated with this prescription drug.
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Sources: FDA iRES · Raw API Response
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