Sterility Concerns Prompt Muscle Relaxant Recall

Nephron Sterile Compounding Center is recalling 38,830 syringes of rocuronium bromide injection, 50 mg/5 mL (10 mg/mL), due to a lack of assurance of sterility, according to the January 18, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recalled rocuronium bromide injections are packaged in 30-syringe cases (NDC 69374-924-05), each containing 6 cartons of 5 prefilled 5-mL syringes, from lot RC2011A (Exp. 2/22/23). The injections were distributed throughout the United States.

Nephron Sterile Compounding Center voluntarily initiated the recall January 6, 2023. On January 9, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Rocuronium bromide injection is prescription drug used as an adjunct to general anesthesia.