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FDAMarch 27, 2018drug

Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

auromedics pharmaauromedics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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