VABRINTY

Generic: LEUPROLIDE ACETATE

URONOVA PHARMACEUTICALSManufacturer
SUBCUTANEOUSRoute
LEUPROLIDE ACETATEActive Substance
2003-02-13Original Approval

VABRINTY is FDA application NDA021488, sponsored by TOLMAR. 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 III2023-09-12
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted befo

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Top Reported Reactions

1
INTERCEPTED PRODUCT PREPARATION ERROR
9,025 reports
2
SYRINGE ISSUE
7,743 reports
3
DEATH
6,446 reports
4
HOT FLUSH
6,301 reports
5
DEVICE LEAKAGE
6,092 reports
6
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
5,333 reports
7
INJECTION SITE PAIN
4,217 reports
8
FATIGUE
3,509 reports
9
PROSTATIC SPECIFIC ANTIGEN INCREASED
1,938 reports
10
ASTHENIA
1,663 reports