AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion,
Recalled May 9, 2018 · FDA recall D-0704-2018 · AuroMedics Pharma
Hazard
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap · FDA Class II
Units
46824 bags
Sold at
US Nationwide
Description
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Product
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →