FLUDEOXYGLUCOSE F-18

Generic: FLUDEOXYGLUCOSE F-18

Precision NuclearManufacturer
INTRAVENOUSRoute
FLUDEOXYGLUCOSE F-18Active Substance
2015-04-07Original Approval

FLUDEOXYGLUCOSE F-18 is FDA application ANDA204546, sponsored by PRECISION NUCLEAR. 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 II2021-02-17
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufacture

Lack of Assurance of Sterility

Top Reported Reactions

1
CYTOKINE RELEASE SYNDROME
20 reports
2
DRUG INEFFECTIVE
16 reports
3
NAUSEA
15 reports
4
OFF LABEL USE
15 reports
5
HYPOTENSION
11 reports
6
PLATELET COUNT DECREASED
11 reports
7
RASH MACULO-PAPULAR
11 reports
8
DEATH
10 reports
9
DYSPNOEA
10 reports
10
NEUTROPENIA
10 reports