US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 20, 2016 (10 years ago)

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Leiter's Compounding
NDC code
70360-007-35
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0012-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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