FDA-Drug2018-08-15Class III
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Baxter Healthcare Corporation
Hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Sold states
Nationwide USA and Puerto Rico
Affected count
711,216 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2018Don't want to check this manually?
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