LEVOFLOXACIN

Generic: LEVOFLOXACIN

Baxter Healthcare CorporationManufacturer

INTRAVENOUSRoute

LEVOFLOXACINActive Substance

2013-06-05Original Approval

LEVOFLOXACIN is FDA application ANDA091436, sponsored by BAXTER HLTHCARE CORP. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2018-03-27

Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion,

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

Class II2022-04-13

Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

cGMP deviations: Temperature abuse

Class III2018-08-01

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentr

Class III2018-08-01

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag,

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentr

Class I2018-01-12

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufacture

Presence of Particulate Matter; contains visible particulate matter identified as mold.

Class III2018-08-01

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag,

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentr

Class II2018-03-27

Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion,

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

Class III2018-09-25

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentr

Class II2017-03-10

Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may re

Class II2018-03-27

Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion,

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

LEVOFLOXACIN

Recalls

Top Reported Reactions