GENTAMICIN SULFATE

Generic: GENTAMICIN SULFATE

Sandoz IncManufacturer
OPHTHALMICRoute
GENTAMICIN SULFATEActive Substance
1980-07-02Original Approval

GENTAMICIN SULFATE is FDA application ANDA062196, sponsored by SANDOZ. 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 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.

Top Reported Reactions

1
DRUG INEFFECTIVE
190 reports
2
ACUTE KIDNEY INJURY
176 reports
3
OFF LABEL USE
168 reports
4
DRUG HYPERSENSITIVITY
153 reports
5
PYREXIA
137 reports
6
RASH
115 reports
7
NAUSEA
105 reports
8
RENAL FAILURE ACUTE
105 reports
9
RENAL FAILURE
101 reports
10
PNEUMONIA
100 reports