March 14, 2019
Leiter's Enterprises Inc. is recalling 569 vials containing cefuroxime 10 mg/mL in sodium chloride intravitreal injection. According to the March 13, 2019, US Food and Drug Administration (FDA) Enforcement Report, the drug was reconstituted using sterile water instead of sterile 0.9% sodium chloride.
The recall affects cefuroxime 10 mg/mL in sodium chloride intravitreal injection, 1 mL in 2-mL vials (NDC 70360-007-35), from lot 1811195 (Exp. 5/1/19). The vials were distributed in California, Arizona, Michigan, and New York.
Leiter's Enterprises voluntarily initiated the recall February 19, 2019. On March 6, 2019, 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.
Cefuroxime is a prescription antibiotic. It can be used to prevent surgical infection when administered intraocularly at the end of a procedure.