D-0518-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2019
- Initiation Date
- February 19, 2019
- Termination Date
- February 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 569 vials
Product Description
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 Pattern
CA, AZ, MI, NY
Code Information
Lot # 1811195, Exp. Date: 05/01/19