DOXORUBICIN HYDROCHLORIDE
Generic: DOXORUBICIN HYDROCHLORIDE
Pfizer Laboratories Div Pfizer IncManufacturer
INTRAVENOUSRoute
DOXORUBICIN HYDROCHLORIDEActive Substance
1987-12-23Original Approval
DOXORUBICIN HYDROCHLORIDE is FDA application NDA050629, sponsored by PFIZER. 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 III2020-11-17
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only,Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class I2026-05-12
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, ManufacturePresence of Particulate matter: Particulate matter identified as glass.
Class II2018-01-16
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun PharmaceLack Of Assurance Of Sterility
Top Reported Reactions
1
FEBRILE NEUTROPENIA
9,168 reports
2
OFF LABEL USE
8,870 reports
3
DISEASE PROGRESSION
6,508 reports
4
NEUTROPENIA
6,454 reports
5
DRUG INEFFECTIVE
5,231 reports
6
PYREXIA
4,101 reports
7
ANAEMIA
3,823 reports
8
THROMBOCYTOPENIA
3,814 reports
9
NAUSEA
3,186 reports
10
DEATH
3,128 reports