Drug Safety Alerts

Cisatracurium Besylate Injection Class I Recall

3/03/2021

On March 3, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Cisatracurium Besylate Injection 10mg/5mL vials. This recall was issued because a carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium.

A complete list of the affected products and lot numbers is provided here.

There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia, and is administered phenylephrine instead, would lead to a lack of skeletal muscle relaxation and an increased risk of elevated blood pressure, arrhythmia and cardiac/brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur.

There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure due to septic shock, who is administered cisatracurium instead, could lead to muscle paralysis and oxygen deprivation. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please contact Meitheal Customer Service at 1-844-824-8426 weekdays from 8:00AM to 6:00PM (CT) or visit www.meithealpharma.com.

You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or

visit https://www.accessdata.fda.gov.