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.
Reported: March 13, 2019 Initiated: February 19, 2019 #D-0518-2019
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.
Details
- Recalling Firm
- Leiter's Enterprises, Inc.
- Units Affected
- 569 vials
- Distribution
- CA, AZ, MI, NY
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Leiter's Enterprises, Inc.. Units affected: 569 vials.
Why was this product recalled? ▼
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2019. Severity: Moderate. Recall number: D-0518-2019.
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