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3/30/2022

Hepatitis B Vaccine (Recombinant)

Products Affected - Description

    • Engerix-B suspension for injection, GlaxoSmithKline, Pediatric/Adolescent Dose 10 mcg/ 0.5mL, 0.5 mL single dose vial, 10 count, NDC 58160-0820-11 - discontinued
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL single dose vial, 1 count, NDC 00006-4995-00 - discontinued

Reason for the Shortage

    • Merck discontinued Recombivax HB 1 mL vials in single count.
    • GlaxoSmithKline has Engerix B products available.

Available Products

    • Engerix-B suspension for injection, GlaxoSmithKline, Pediatric/Adolescent Dose 10 mcg/ 0.5mL, 0.5 mL syringe, 10 count, NDC 58160-0820-52
    • Engerix-B suspension for injection, GlaxoSmithKline, Adult Dose 20 mcg/mL, 1 mL single dose vial, 10 count, NDC 58160-0821-11
    • Engerix-B suspension for injection, GlaxoSmithKline, Adult Dose 20 mcg/mL, 1 mL syringe, 10 count, NDC 58160-0821-52
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL Luer Lock syringe, 10 count, NDC 00006-4094-02
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL single dose vial, 10 count, NDC 00006-4995-41
    • Recombivax HB suspension for injection, Merck, Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL Luer Lock syringe, 10 count, NDC 00006-4093-02
    • Recombivax HB suspension for injection, Merck, Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL single dose vial, 10 count, NDC 00006-4981-00
    • Recombivax HB Dialysis Formulation suspension for injection, Merck, Dialysis Formulation 40 mcg/mL, 1 mL single dose vial, 1 count, NDC 00006-4992-00

Estimated Resupply Dates

    • All marketed presentations are available.

Implications for Patient Care

    • Recombivax HB adult and pediatric formulations are labeled for use in any age group as long as the correct volume/dose is given.
    • Engerix-B adult formulation may be used in patients aged 11 years and older. The pediatric formulation is only approved for patients under 20 years old.
    • More information on dosing of these medications can be found in the product labeling as well as the CDC site at https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf

Updated

Updated March 30, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 16, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2022, 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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