Leiter's Enterprises, Inc. recalls Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only
Recalled March 13, 2019 · FDA recall D-0518-2019 · Leiter's Enterprises
Hazard
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. · FDA Class II
Units
569 vials
Sold at
CA, AZ, MI, NY
Description
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Product
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
Manufacturer(s)
Leiter's Enterprises, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →