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1/14/2021

Albuterol Sulfate Metered Dose Inhalers

Products Affected - Description

    • Albuterol Sulfate HFA inhalation aerosol, Lupin, 0.09 mg/1 actuation, 8.5 gram metered dose inhaler, 1 count, NDC 68180-0963-01
    • Albuterol Sulfate HFA inhalation aerosol, Perrigo, 0.09 mg/1 actuation, 8.5 gram metered dose inhaler, 1 count, NDC 45802-0088-01
    • Albuterol Sulfate HFA inhalation aerosol, Prasco, 0.09 mg/1 actuation, 18 gram metered dose inhaler, 1 count, NDC 66993-0019-68
    • Albuterol Sulfate HFA inhalation aerosol, Teva, 0.09 mg/1 actuation, 8.5 gram metered dose inhaler, 1 count, NDC 00093-3174-31

Reason for the Shortage

    • GlaxoSmithKline has Ventolin HFA inhalers available.
    • Cipla has albuterol HFA inhalers available.
    • Lupin is allocating albuterol inhalers to forecast to ensure equitable distribution.
    • Merck has Proventil HFA inhalers available.
    • Par has albuterol HFA inhalers available.
    • Perrigo recalled albuterol inhalers in September 2020 due to possible clogging of the inhalers. Additional information can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall.
    • Prasco has albuterol HFA inhalers on allocation.
    • Teva did not provide a reason for the shortage of albuterol HFA inhalers. The company has ProAir HFA inhalers available. Teva's dry powder inhalers (ProAir Respiclick and ProAir Digihaler) are not affected by this shortage.

Available Products

    • Albuterol Sulfate HFA inhalation aerosol, Cipla USA, 0.09 mg/1 actuation, 6.7 gram metered dose inhaler, 1 count, NDC 69097-0142-60
    • Albuterol Sulfate HFA inhalation aerosol, Par Pharmaceuticals, 0.09 mg/1 actuation, 6.7 gram metered dose inhaler, 1 count, NDC 00254-1007-52
    • ProAir HFA inhalation aerosol, Teva, 0.09 mg/1 actuation, 8.5 gram metered dose inhaler, 1 count, NDC 59310-0579-22
    • Proventil HFA inhalation aerosol, Merck, 0.09 mg/1 actuation, 6.7 gram metered dose inhaler, 1 count, NDC 00085-1132-04
    • Ventolin HFA inhalation aerosol, GlaxoSmithKline, 0.09 mg/1 actuation, 18 gram metered dose inhaler, 1 count, NDC 00173-0682-20
    • Ventolin HFA inhalation aerosol, GlaxoSmithKline, 0.09 mg/1 actuation, 8 gram metered dose inhaler, 1 count, NDC 00173-0682-24

Estimated Resupply Dates

    • Lupin has albuterol HFA 8.5 gram inhalers on allocation.
    • Prasco has albuterol HFA 18 gram inhalers on allocation.
    • Teva has albuterol HFA 8.5 gram inhalers on back order and the company estimates a release date in early-February 2020.

Safety

    • FDA has listed extended-dating for several lots of Ventolin HFA. These extended dates can be found at https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages.

Updated

Updated January 14, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 23, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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