BIVALIRUDIN

Generic: BIVALIRUDIN

Meitheal Pharmaceuticals Inc.Manufacturer
INTRAVENOUSRoute
BIVALIRUDINActive Substance
2018-07-16Original Approval

BIVALIRUDIN is FDA application ANDA091602, 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 II2023-07-03
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27

Presence of Particulate Matter: Particulate matter identified as fiber.

Top Reported Reactions

1
DRUG INEFFECTIVE
185 reports
2
OFF LABEL USE
108 reports
3
HAEMORRHAGE
87 reports
4
HEPARIN-INDUCED THROMBOCYTOPENIA
74 reports
5
GASTROINTESTINAL HAEMORRHAGE
43 reports
6
VASCULAR STENT THROMBOSIS
39 reports
7
THROMBOSIS
38 reports
8
ACUTE MYOCARDIAL INFARCTION
35 reports
9
HYPOTENSION
33 reports
10
THROMBOSIS IN DEVICE
33 reports