Hepatitis B Vaccine (Recombinant) Shortage
Last Updated: March 30, 2022
Status: Current
Products Affected - Description
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- 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
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- Merck discontinued Recombivax HB 1 mL vials in single count.
- GlaxoSmithKline has Engerix B products available.
Available Products
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- 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
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- All marketed presentations are available.
Implications for Patient Care
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- 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.