MILRINONE LACTATE
Generic: MILRINONE LACTATE
Meitheal Pharmaceuticals Inc.Manufacturer
INTRAVENOUSRoute
MILRINONE LACTATEActive Substance
2020-03-24Original Approval
MILRINONE LACTATE is FDA application ANDA211671, 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 II2017-05-15
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter HeaLack of assurance of sterility: customer complaints received for the presence of leaks.
Class III2023-08-14
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single Failed Impurities/Degradation Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
89 reports
2
HYPOTENSION
16 reports
3
RENAL FAILURE
13 reports
4
CARDIAC FAILURE
12 reports
5
DYSPNOEA
11 reports
6
CARDIAC ARREST
10 reports
7
OFF LABEL USE
10 reports
8
VENTRICULAR TACHYCARDIA
10 reports
9
HAEMORRHAGE
9 reports
10
MULTI-ORGAN FAILURE
9 reports