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5/29/2020

Albuterol Sulfate Metered Dose Inhalers

Products Affected - Description

    • 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
    • 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

Reason for the Shortage

    • GlaxoSmithKline is allocating to wholesale customers in an effort to ensure equitable distribution of available product. Customers must place orders through their wholesalers.
    • Merck has Proventil HFA inhalers available.
    • Par has albuterol HFA inhalers available.
    • Prasco is allocating product due to increased demand.
    • Teva did not provide a reason for the shortage. Teva's dry powder inhalers (ProAir Respiclick and ProAir Digihaler) are not affected by this shortage.

Available Products

    • 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

Estimated Resupply Dates

    • GlaxoSmithKline has Ventolin HFA 8 gram inhalers on back order and the company estimates a release date in late-3rd quarter 2020. Ventolin HFA 18 gram inhalers are on allocation.
    • Prasco has albuterol sulfate HFA 18 gram inhalers on allocation.
    • Teva has albuterol sulfate HFA 8.5 gram inhalers on intermittent back order and the company is releasing supplies as they become available.

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 May 29, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 23, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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