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6/13/2022

Labetalol Injection

Products Affected - Description

    • Labetalol injection, Akorn, 5 mg/mL, 20 mL vial, 1 count, NDC 17478-0420-20
    • Labetalol injection, Akorn, 5 mg/mL, 40 mL vial, 1 count, NDC 17478-0420-40
    • Labetalol injection, Almaject, 5 mg/mL, 20 mL vial, 1 count, NDC 47781-0586-29
    • Labetalol injection, Almaject, 5 mg/mL, 40 mL vial, 1 count, NDC 47781-0586-56
    • Labetalol injection, Baxter, 5 mg/mL, 20 mL vial, 1 count, NDC 36000-0322-02
    • Labetalol injection, Baxter, 5 mg/mL, 4 mL vial, 10 count, NDC 36000-0320-10
    • Labetalol injection, Baxter, 5 mg/mL, 40 mL vial, 1 count, NDC 36000-0324-02
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 20 mL vial, 1 count, NDC 72266-0102-01
    • Labetalol injection, Fosun Pharma, 5 mg/mL, 40 mL vial, 1 count, NDC 72266-0103-01
    • Labetalol injection, Hikma, 5 mg/mL, 20 mL vial, 1 count, NDC 00143-9622-01
    • Labetalol injection, Hikma, 5 mg/mL, 40 mL vial, 1 count, NDC 00143-9623-01
    • Labetalol injection, Hikma, In 0.72% sodium chloride 100 mg/100 mL premixed bag, 10 count, NDC 00143-9363-10
    • Labetalol injection, Hikma, In 5% dextrose 200 mg/200 mL premixed bag, 10 count, NDC 00143-9366-10
    • Labetalol injection, Pfizer, 5 mg/mL, 20 mL vial, 1 count, NDC 00409-2267-20
    • Labetalol injection, Pfizer, 5 mg/mL, 4 mL Carpuject syringe, 10 count, NDC 00409-2339-34
    • Labetalol injection, Pfizer, 5 mg/mL, 40 mL vial, 1 count, NDC 00409-2267-54

Reason for the Shortage

    • Akorn did not provide a reason for the shortage.
    • Almaject did not provide a reason for the shortage.
    • Baxter has labetalol injection on shortage due to increased demand.
    • Fosun did not provide a reason for the shortage.
    • Hikma has labetalol vials available. The premixes are available as well.
    • Pfizer has labetalol injection on shortage due to increased demand and manufacturing delays.

Available Products

    • Labetalol injection, Hikma, In 0.72% sodium chloride 200 mg/200 mL premixed bag, 10 count, NDC 00143-9364-10
    • Labetalol injection, Hikma, In 0.72% sodium chloride 300 mg/300 mL premixed bag, 10 count, NDC 00143-9365-10

Estimated Resupply Dates

    • Akorn has short-dated labetalol 5 mg/mL 20 mL and 40 mL vials available.
    • Almaject has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a release date of June 2022.
    • Baxter has labetalol 5 mg/mL 4 mL, 20 mL, and 40 mL vials available in limited supply.
    • Fosun has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.
    • Hikma has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a release date of late-June to early-July 2022 for the 20 mL vials and late-September 2022 for the 40 mL vials. There are short-dated 100 mg/100 mL premixed bags in 0.72% sodium chloride with an expiration date of March 2023. There are short-dated 200 mg/200 mL premixed bags in 5% dextrose available with an expiration date of February 2023.
    • Pfizer has labetalol 5 mg/mL 4 mL Luer-Lock syringes on back order and the company estimates a release date of June 2022. The 20 mL and 40 mL vials are available in limited supply.

Updated

Updated June 13, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 19, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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