Cholinesterase Inhibitor Recalled

Nephron Sterile Compounding Center is recalling 56,220 vials of neostigmine methylsulfate injection due to a potential for cross contamination, according to the November 23, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects PF-Neostigmine Methylsulfate Injection in 3 mg/3 mL (1 mg/mL) vials (NDC 69374-932-33, UPC 3 69374-93233 2) from lots NE1062A and NE1062B (Exp. 12/2/22), NE1065A and NE1065B (Exp. 12/13/22), and NE2011A and NE2011B (Exp. 3/15/22). The product was distributed throughout the United States.

Nephron Sterile Compounding Center voluntarily initiated the recall November 10, 2022. The FDA designated the recall Class II on November 17, 2022, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Neostigmine methylsulfate injection is a prescription medication used to reverse the effects of nondepolarizing neuromuscular blocking agents after surgery.