Meitheal Pharmaceuticals Inc. is recalling 34,860 vials of Cisatracurium Besylate Injection, USP (10 mg per 5 mL). This recall was initiated because some cartons were found to contain vials mislabeled as Phenylephrine Hydrochloride Injection, USP, even though the vials actually contain Cisatracurium. These products were distributed nationwide in the United States and were sold in cartons containing ten 5 mL single-dose vials.
Cisatracurium is a potent muscle relaxant used during surgery or with breathing machines; if it is mistaken for Phenylephrine (a blood pressure medication) and administered to a patient who is not sedated or being mechanically ventilated, it can cause respiratory failure, permanent airway damage, or death.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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