Meitheal Pharmaceuticals announced the voluntary recall of 1 lot of Cisatracurium Besylate Injection 10mg/5mL due to mislabeling.
The recalled lot, Cisatracurium Besylate Injection 10mg/5mL; NDC# 71288-712-06, 71288-712-05; Lot Number C11507A; Expiry Date October 2021, was distributed nationwide to wholesalers between August 19, 2020 and January 4, 2021. The recall was initiated after a product complaint revealed that a portion of the lot contained vials mislabeled as Phenylephrine Hydrochloride Injection 100mg/10mL.
Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated as an adjunct to general anesthesia, to facilitate non-emergency endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
According to Meitheal Pharmaceuticals, if a patient who requires cisatracurium is administered phenylephrine, elevated blood pressure, arrhythmia and cardiac/brain ischemia may occur. Conversely, if a patient who requires phenylephrine is administered cisatracurium, it may result in the fast onset of muscle paralysis and a decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur.
To date, the Company has not received any reports of adverse events related to this recall. The Company has notified its distributors and customers in writing to arrange for return of all affected products. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding this recall contact Meitheal Pharmaceuticals by calling (844) 824-8426.
Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling. [press release]. Chicago, IL: Meitheal Pharmaceuticals, Inc; January 27, 2021.