BENDAMUSTINE HYDROCHLORIDE

Generic: BENDAMUSTINE HYDROCHLORIDE

Baxter Healthcare CorporationManufacturer
INTRAVENOUSRoute
BENDAMUSTINE HYDROCHLORIDEActive Substance
2022-12-15Original Approval

BENDAMUSTINE HYDROCHLORIDE is FDA application NDA216078, sponsored by BAXTER HLTHCARE CORP. 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 III2023-08-14
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcar

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled

Top Reported Reactions

1
OFF LABEL USE
993 reports
2
PYREXIA
552 reports
3
DISEASE PROGRESSION
510 reports
4
COVID-19
405 reports
5
PRODUCT USE IN UNAPPROVED INDICATION
400 reports
6
DRUG INEFFECTIVE
389 reports
7
FEBRILE NEUTROPENIA
367 reports
8
MALIGNANT NEOPLASM PROGRESSION
360 reports
9
NEUTROPHIL COUNT DECREASED
352 reports
10
NEUTROPENIA
344 reports