Septodont Inc. has recalled approximately 8,509 boxes of OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7mL. The recall was initiated after testing discovered an out-of-specification level of Phentolamide, which is a known impurity that forms as the drug degrades over time. These products were distributed in the United States, Italy, and France. If you have this medication, you should consult your healthcare provider or pharmacist regarding the continued use of the product and return any unused units for a refund.
The presence of degradation impurities at levels higher than specified can potentially alter the drug's safety or effectiveness, though the risk is currently categorized as low. This specific impurity, Phentolamide, was detected during a 15-month stability test point.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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