MIDAZOLAM
Generic: MIDAZOLAM
Hikma Pharmaceuticals USA Inc.Manufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
MIDAZOLAM HYDROCHLORIDEActive Substance
2000-06-20Original Approval
MIDAZOLAM is FDA application ANDA075243, sponsored by HIKMA. 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 II2012-09-27
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. ScLack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class I2017-10-27
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton,Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Contain
Class II2016-12-16
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC ScFailed Impurities/Degradation Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
3,405 reports
2
OFF LABEL USE
2,557 reports
3
HYPOTENSION
1,575 reports
4
DRUG INTERACTION
1,247 reports
5
SEIZURE
1,198 reports
6
PYREXIA
960 reports
7
CARDIAC ARREST
937 reports
8
TOXICITY TO VARIOUS AGENTS
937 reports
9
ACUTE KIDNEY INJURY
928 reports
10
DEATH
733 reports