Drugplain

Dobutamine 12.5 mg/mL

Dobutamine · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.

9 Recalls on RecordCurrently in Shortage
Plain English

Dobutamine is a injection, solution containing dobutamine at 12.5 mg/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name
Dobutamine
Generic Name
Dobutamine
NDC Code (Product)
0143-9141
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
12.5 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA074277
Marketing Start
05/03/2023

Recall History

9 Recalls on Record
Class I01/10/2014

Hospira Inc.

Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.

TerminatedVoluntary: Firm initiated
Class II12/26/2014

Walgreens Infusion Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II04/30/2013

Hospira Inc.

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

TerminatedVoluntary: Firm initiated
Class II12/27/2022

Sentara Infusion Services

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II05/28/2025

Pfizer Inc.

Discoloration; discolored solution from cracked vials

OngoingVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II09/18/2015

Sentara Enterprises

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

TerminatedVoluntary: Firm initiated
Class II04/18/2016

Baptist Health Medical Towers Pharmacy and Infusion Services

Lack of Sterility Assurance.

TerminatedVoluntary: Firm initiated
Class II08/15/2016

Hospira Inc.

Discoloration: Firm received complaints of product discoloration and particulates.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective867 reports
off label use604 reports
death491 reports
cardiogenic shock457 reports
multiple organ dysfunction syndrome421 reports
condition aggravated406 reports
sepsis403 reports
general physical health deterioration344 reports
nausea340 reports
stress336 reports

Frequently Asked Questions

What is Dobutamine used for?

Dobutamine contains Dobutamine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Dobutamine a controlled substance?

Dobutamine is not classified as a controlled substance by the DEA.

What is the generic name for Dobutamine?

The generic name for Dobutamine is Dobutamine. There are 10 other brand versions of Dobutamine.

What is the NDC code for Dobutamine 12.5 mg/mL?

The NDC (National Drug Code) for Dobutamine 12.5 mg/mL is 0143-9141, listed by Hikma Pharmaceuticals USA Inc..