Levofloxacin in 5% Dextrose Injection recalled over sterility concerns

Recall date

March 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion…

Recall number

D-0708-2018

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

US Nationwide

Why it was recalled

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47