FDA – January 27, 2021 – A voluntary recall alert was published by the U.S. Food and Drug Administration, Meitheal Pharmaceuticals, Inc. has issued a nationwide recall of its Cisatracurium Besylate Injection, USP 10mg per 5mL, because of a dangerous mislabeling error.
The FDA alert is reporting that Meitheal Pharmaceuticals, Inc. (“Meitheal”), has announced today that it recalled one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL at the patient level. The reason for the product recall was made following patient complaints revealed that a part of Lot C11507A because some cartons that were labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, contained 10-vials mislabeled as “Phenylephrine Hydrochloride Injection, USP 100mg per 10mL.” At this time, Meitheal denies that the company received any reports of injuries or deaths caused by the mislabeling error.
Serious Medical Complications Concerning the Mislabeling Error
Should a patient who needs a dose of cisatracurium for muscle paralysis while undergoing general anesthesia is accidentally administered phenylephrine, the patient will not go into skeletal muscle relaxation resulting in a hyperadrenergic state resolution causing heart arrhythmia, elevated blood pressure, cardiac ischemia, and brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur.
Further, a patient who needs phenylephrine to raise their blood pressure, especially septic shock-related low blood pressure which is given cisatracurium, could go into muscle paralysis and sustain a severe decrease in oxygen saturation levels. If the adverse event is not quickly diagnosed and treated, critical illness or death could occur within a few minutes.
Cisatracurium Besylate Injection is a medication that functions as a nondepolarizing neuromuscular blocker. The recalled Cisatracurium Besylate Injection lot under recall is C11507A, with an expiration date of October 2021. The recalled product may be identified as a 5mL vial with a rubber stopper and is sealed with an aluminum seal with an Aqua color flip-off seal. Meitheal began shipping the medication to customers on August 19, 2020. The recalled cisatracurium was distributed to wholesalers throughout the United States.
Meitheal has contacted its customers and distributors in writing to set up a return of the recalled medications. Customers who purchased the recalled drug should not open the packaging or use the medications. Customers are asked to pull the medications off of supply shelves and to return the recalled lot of medications immediately. Buyers who may have distributed the recalled medications should immediately contact their customers and inform them immediately of this recall.
The Cisatracurium Besylate Injection, USP 10mg per 5mL recall is being conducted with the U.S. Food and Drug Administration’s knowledge.
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