FDA-Drug2018-05-09Class II
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
AuroMedics Pharma LLC
Hazard
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Sold states
US Nationwide
Affected count
308112 bags
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0709-2018Don't want to check this manually?
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