BLEOMYCIN

Generic: BLEOMYCIN

HospiraManufacturer
INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUSRoute
BLEOMYCIN SULFATEActive Substance
2000-03-10Original Approval

BLEOMYCIN is FDA application ANDA065031, sponsored by HOSPIRA. 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 I2023-12-21
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc

Presence of particulate matter: glass

Class III2021-08-05
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G

Labeling: Not elsewhere classified: Mislabeling

Top Reported Reactions

1
FEBRILE NEUTROPENIA
826 reports
2
OFF LABEL USE
790 reports
3
NEUTROPENIA
599 reports
4
DRUG INEFFECTIVE
506 reports
5
PYREXIA
464 reports
6
PULMONARY TOXICITY
415 reports
7
VOMITING
370 reports
8
NAUSEA
367 reports
9
ANAEMIA
356 reports
10
THROMBOCYTOPENIA
354 reports