AuroMedics Pharma LLC has voluntarily recalled 4,600 vials of Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL). This medication, often used during surgery to reduce secretions or protect the heart, was found to have elevated levels of a chemical impurity called benzaldehyde during routine quality testing. This recall affects specific 20 mL multiple-dose vials that were distributed to hospitals and medical facilities in Louisiana, Mississippi, and Ohio.
The presence of elevated benzaldehyde impurities means the medication does not meet quality specifications, which could potentially lead to adverse reactions or reduced effectiveness of the treatment. While the risk is categorized as low, using a drug with unexpected chemical degradation may pose health risks to patients receiving the injection.
Product return and refund
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Sources: FDA iRES · Raw API Response
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