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2/17/2021

Haloperidol Lactate Injection

Products Affected - Description

    • Haldol solution for injection, Janssen, 5 mg/mL, 1 mL ampule, 10 count, NDC 50458-0255-01 - discontinued
    • Haloperidol lactate solution for injection, Fresenius Kabi, 5 mg/mL, 1 mL vial, 25 count, NDC 63323-0474-01
    • Haloperidol lactate solution for injection, Hikma, 5 mg/mL, 1 mL vial, 25 count, NDC 00143-9501-25
    • Haloperidol lactate solution for injection, Mylan Institutional, 5 mg/mL, 1 mL vial, 25 count, NDC 67457-0426-12
    • Haloperidol lactate solution for injection, Patriot Pharmaceuticals, 5 mg/mL, 1 mL ampule, 10 count, NDC 10147-0911-01 - discontinued
    • Haloperidol lactate solution for injection, Sagent, 5 mg/mL, 1 mL vial, 10 count, NDC 25021-0806-01

Reason for the Shortage

    • Fresenius Kabi has haloperidol lactate injection on shortage due to increased demand.
    • Hikma did not provide a reason for the shortage.
    • Janssen discontinued Haldol injection in November 2020.
    • Mylan Institutional did not provide a reason for the shortage.
    • Patriot Pharmaceuticals discontinued haloperidol lactate injection in November 2020.
    • Sagent has haloperidol lactate injection on shortage due to increased demand.

Available Products

    • Haloperidol lactate injection, Fresenius Kabi, 5 mg/mL, 1 mL Simplist prefilled syringe, 24 count, NDC 76045-0737-10
    • Haloperidol lactate solution for injection, Fresenius Kabi, 5 mg/mL, 10 mL vial, 1 count, NDC 63323-0474-10
    • Haloperidol lactate solution for injection, Hikma, 5 mg/mL, 10 mL vial, 1 count, NDC 00143-9502-01

Estimated Resupply Dates

    • Fresenius Kabi has haloperidol lactate injection 5 mg/mL vials on back order and the company estimates a release date of early-March 2021.
    • Hikma has haloperidol lactate injection 5 mg/mL vials on back order and the company estimates a release date of 4th quarter 2021.
    • Mylan Institutional has haloperidol lactate injection 5 mg/mL vials on back order and the company estimates a release date of early-March 2021.
    • Sagent has haloperidol lactate 5 mg/mL 1 mL vials on back order and the company estimates a release date of April 2021.

Updated

Updated February 17, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 9, 2020 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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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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