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 Onl…

Recall date

February 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0518-2019

FDA classification

Class II

Brand / firm

Leiter's Enterprises, Inc.

Sold / distributed

CA, AZ, MI, NY

Why it was recalled

Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.