BUSULFAN

Generic: BUSULFAN

Meitheal Pharmaceuticals Inc.Manufacturer
INTRAVENOUSRoute
BUSULFANActive Substance
2020-10-23Original Approval

BUSULFAN is FDA application ANDA212127, sponsored by MEITHEAL. 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 III2026-05-04
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,

Failed Impurities/Degradation Specifications

Top Reported Reactions

1
OFF LABEL USE
1,994 reports
2
PRODUCT USE IN UNAPPROVED INDICATION
1,707 reports
3
MUCOSAL INFLAMMATION
1,071 reports
4
DRUG INEFFECTIVE
1,059 reports
5
GRAFT VERSUS HOST DISEASE
897 reports
6
VENOOCCLUSIVE LIVER DISEASE
865 reports
7
CYTOMEGALOVIRUS INFECTION
861 reports
8
FEBRILE NEUTROPENIA
829 reports
9
ACUTE GRAFT VERSUS HOST DISEASE
816 reports
10
PYREXIA
807 reports