Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cefuroxime 10 mg/mL in Sodium Chloride Recalled by Leiter's Enterprises, Inc. Due to Incorrect Product Formulation; compounded sterile drug reconstituted using...

Date: February 19, 2019
Company: Leiter's Enterprises, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Leiter's Enterprises, Inc. directly.

Affected Products

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.

Quantity: 569 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 4 states: AZ, CA, MI, NY

Affected (4 states)Not affected

About Leiter's Enterprises, Inc.

Leiter's Enterprises, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report