FDA recall D-0518-2019

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.

Reason for recall

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

Distribution

CA, AZ, MI, NY

Key facts

Status

Terminated

Initiation date

2019-02-19

Report date

2019-03-13

Termination date

2020-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2019