DOBUTAMINE
Generic: DOBUTAMINE
Hikma Pharmaceuticals USA Inc.Manufacturer
INTRAVENOUSRoute
DOBUTAMINE HYDROCHLORIDEActive Substance
1994-10-31Original Approval
DOBUTAMINE is FDA application ANDA074277, 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 I2014-01-10
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., LakPresence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vi
Class II2013-04-30
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 6Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Class II2025-05-28
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, FDiscoloration; discolored solution from cracked vials
Top Reported Reactions
1
DRUG INEFFECTIVE
891 reports
2
OFF LABEL USE
634 reports
3
DEATH
494 reports
4
CARDIOGENIC SHOCK
485 reports
5
MULTIPLE ORGAN DYSFUNCTION SYNDROME
449 reports
6
CONDITION AGGRAVATED
431 reports
7
SEPSIS
427 reports
8
GENERAL PHYSICAL HEALTH DETERIORATION
368 reports
9
NAUSEA
366 reports
10
STRESS
361 reports