Muscle Relaxant Recalled

Piramal Critical Care Inc is recalling two lots of rocuronium bromide injection because the vial flip caps lack a statement warning the drug is a paralyzing agent. The recall was included in the October 27, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects rocuronium bromide injection 50 mg/5 mL, 5-mL multi-dose vials (NDC 66794-228-41) from lots 20415001 and 20415002 (Exp. 5/22). The vials were manufactured for Piramal Critical Care, Bethlehem, PA, by Sanovel Ilac, Istanbul, Turkey, and distributed throughout the United States. 

Piramal Critical Care Inc. voluntarily initiated the recall September 10, 2021. The FDA designated the recall Class II on October 20, 2021. The use of drugs under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Rocuronium bromide is a prescription injection used to relax muscles during surgery and medical procedures.