FDA-Drug2017-04-05Class II
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Claris Lifesciences Inc
Hazard
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Sold states
Nationwide
Affected count
24,456 units (1019 cartons x 24 bags)
Manufactured in
1445 US Highway 130, North Brunswick, NJ, United States
Products
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0615-2017Don't want to check this manually?
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