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Labeling Error Prompts Class I Recall


March 05, 2021

A Class I recall has been issued for a single lot of cisatracurium besylate injection from Meitheal Pharmaceuticals Inc. According to the March 3, 2021, US Food and Drug Administration (FDA) Enforcement Report, a carton of cisatracurium besylate injection contained 10 vials mislabeled as phenylephrine hydrochloride injection. 

Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker used before and during surgery. Phenylephrine hydrochloride injection is used to treat low blood pressure during surgery. 

The recall affects 34,860 single-dose vial of cisatracurium besylate injection, 10 mg/5 mL (2 mg/mL; NDC 71288-712-05), packaged as 10 x 5-mL single-dose vials per carton (NDC 71288-712-06), manufactured for Meitheal Pharmaceuticals, from lot C11507A (Exp. 10/21). Mislabeled products would have the same lot number and expiration date, but the vials would be labeled as phenylephrine hydrochloride injection, 100 mg/10 mL, NDC 71288-808-77 (unit of use). 

“The product can be identified as a 5-mL vial stoppered with a rubber stopper and sealed with aluminum seal having an aqua color flip-off seal,” Meitheal Pharmaceuticals explained in a January 27, 2021, statement announcing the voluntary recall. “Meitheal commenced shipping the product to customers on August 19, 2020, which was distributed to wholesalers nationwide in the United States.”

All recalled products from the lot should be quarantined and returned, the company stated. The Class 1 designation issued by the FDA on February 22, 2021, warns use of the affected product could cause serious adverse health consequences or death. 

“There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia, and cardiac/brain ischemia,” Meitheal Pharmaceuticals wrote. 

“There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock, who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen,” the company added. 

In either case, severe illness or death could occur within minutes if not treated. As of January 27, 2021, Meitheal Pharmaceuticals had not received any reports of adverse events related to injections from the lot.

Jolynn Tumolo

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