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The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.
Meitheal Pharmaceuticals announced on Jan. 27, 2021 that is voluntarily recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL after a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL was found to contain 10 vials mislabeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL.
According to the company, Cisatracurium Besylate Injection is a “nondepolarizing neuromuscular blocker”, and if a patient received phenylephrine instead of cisatracurium as part of general anesthesia, it “could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia, and cardiac/brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur.”
The affected lot, C11507A, EXP. October 2021, was distributed to wholesalers nationwide in the United States. The company has not received any reports of adverse events associated with the recalled lot as of Jan. 27, 2021. Adverse events may be reported to FDA via the agency’s MedWatch program.