FDA-Drug2019-03-13Class II
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.
Leiter's Enterprises, Inc.
Hazard
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Sold states
CA, AZ, MI, NY
Affected count
569 vials
Manufactured in
17 Great Oaks Blvd, N/A, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2019Don't want to check this manually?
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