Reported Mar 13, 2019 · Terminated
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use…
Leiter's Enterprises, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leiter's Enterprises, Inc. · 17 Great Oaks Blvd · San Jose, CA · 95119-1359
Is this the product you have?
- 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
- NDC70360-007-35
- Lot codes and dates
- Lot # 1811195, Exp
- Date05/01/19
- Amount recalled
- 569 vials
Where it was sold
Why it was recalled
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
This product could cause temporary or reversible health problems — stop using it.
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