Drug 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.
D-0518-2019
Product summary
- Event
- Event 82229
- Status
- Terminated
- Classification
- Class II
- Quantity
- 569 vials
- Official record key
drug-enforcement:D-0518-2019
Official wording
Reason: Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Code information: Lot # 1811195, Exp. Date: 05/01/19
Distribution pattern: CA, AZ, MI, NY
Derived failure modes
-
Unknown
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.