GENTAMICIN
Generic: GENTAMICIN
Eugia US LLCManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
GENTAMICIN SULFATEActive Substance
2024-01-08Original Approval
GENTAMICIN is FDA application ANDA215236, sponsored by EUGIA PHARMA. 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 II2014-11-12
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP PharmaceuticalDefective Container: Vials may be missing stoppers.
Class II2013-05-02
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Presence of Particulate Matter: visible particles were identified floating in the primary container.
Class II2025-05-29
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India foFailed Stability Specifications: Out of specification results for the Color Absorbance test during
Top Reported Reactions
1
DRUG INEFFECTIVE
1,248 reports
2
ACUTE KIDNEY INJURY
1,204 reports
3
PYREXIA
898 reports
4
OFF LABEL USE
870 reports
5
RENAL FAILURE
707 reports
6
DIARRHOEA
563 reports
7
SEPSIS
507 reports
8
CONDITION AGGRAVATED
504 reports
9
HYPOTENSION
491 reports
10
NAUSEA
486 reports