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 Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 Recalled by Leiter's Compounding Due to Lack of Assurance of Sterility; all compounded products...

Date: September 20, 2016
Company: Leiter's Compounding
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 Compounding directly.

Affected Products

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

Quantity: 76,315 total units, all products

Why Was This Recalled?

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Leiter's Compounding

Leiter's Compounding has 9 total recalls tracked by RecallDetector.

Related Recalls

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