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Hepatitis B Vaccine (Recombinant)

Last Updated: March 30, 2022
Status: Current

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.