LINEZOLID
Generic: LINEZOLID
Ascend LaboratoriesManufacturer
ORALRoute
LINEZOLIDActive Substance
2015-12-21Original Approval
LINEZOLID is FDA application ANDA205517, sponsored by ALKEM LABS LTD. 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 I2017-12-20
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laPresence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class II2018-03-27
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo PharLack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t
Top Reported Reactions
1
OFF LABEL USE
2,314 reports
2
DRUG INEFFECTIVE
1,853 reports
3
THROMBOCYTOPENIA
1,755 reports
4
ANAEMIA
1,439 reports
5
DRUG INTERACTION
1,173 reports
6
NAUSEA
1,034 reports
7
LACTIC ACIDOSIS
905 reports
8
VOMITING
872 reports
9
NEUROPATHY PERIPHERAL
863 reports
10
ACUTE KIDNEY INJURY
861 reports