Skip to content

    Asthma Health Center

    Font Size

    Recall of Albuterol Used in Nebulizers

    Mislabeling on Some Single-Dose Vials Could Lead to Possible Overdose
    WebMD Health News
    Reviewed by Louise Chang, MD

    Jan 3, 2011 -- The Ritedose Corporation has recalled some single-dose vials of Albuterol Sulfate Inhalation Solution because an incorrect label could lead to a possible overdose.

    The recall includes 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25-, 30-, and 60-unit dose vials) because the 2.5 mg/3 mL single-use vials are mislabeled as containing 0.5 mg/3 mL.

    The product is a prescription inhalation solution that is administered with a nebulizer to treat acute asthma attacks and exercise-induced asthma in children and adults.

    If someone reads the incorrect concentration, he or she may upwardly adjust the volume, resulting in an administered amount that is five times the recommended dose.

    Symptoms of albuterol overdose include tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, rapid heart rates up to 200 beats/minutes, and potentially death.

    The recalled solution is contained in single-use vials in a protective foil overwrap packaged in a shelf carton. The correct concentration is, however, labeled on the primary foil overwrap pouches and shelf cartons. In the hospital setting, the vials are often not accompanied by the rest of the packaging.

    Recalled Lot Numbers

    The recalled lot numbers are manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60.

    They include:

    • 0N81
    • 0N82
    • 0N83
    • 0N84
    • 0NE7
    • 0NE8
    • 0NE9
    • 0NF0
    • 0P12
    • 0P13
    • 0P46
    • 0P47
    • 0PF0
    • 0S15

    These products were distributed nationwide and in Puerto Rico.

    Consumers should immediately return the affected product to where it was obtained.

    Those with questions should contact the company at 803-935-3995 Monday through Friday 8am to 5pm EST or send an e-mail to

    When Is Your Asthma Worse?

    When Is Your Asthma Worse?

    Take the WebMD Asthma assessment to get Personalized Action Plan

    Start Now

    Today on WebMD

    Lung and bronchial tube graphic
    5 common triggers.
    group jogging in park
    Should you avoid fitness activities?
    asthma inhaler
    Learn about your options.
    man feeling faint
    What’s the difference?
    Madison Wisconsin Capitol
    woman wearing cpap mask
    red wine pouring into glass
    Woman holding inhaler
    Man outdoors coughing
    Lung and bronchial tube graphic
    10 Worst Asthma Cities