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  4. CBER-Regulated Products: Resolved Shortages
  1. Safety & Availability (Biologics)

CBER-Regulated Products: Resolved Shortages

The table below provides a listing of resolved CBER-regulated product shortages. CBER works closely with the manufacturer to voluntarily obtain accurate information and is committed to ensuring that the information in the table below is current.

Tabular Listing of Resolved CBER-Regulated Product Shortages

Product Manufacturer Manufacturer Contact Information Additional Information Resolved Date
Immune Globulin Infusion (Human)
GAMMAGARD LIQUID®

NDC Number:
0944-2700-02
10mL, 1.0 Grams Protein

NDC Number:
0944-2700-03
25mL, 2.5 Grams Protein

NDC Number:
0944-2700-04
50mL, 5.0 Grams Protein

NDC Number:
0944-2700-05
100mL, 10.0 Grams Protein

NDC Number:
0944-2700-06
200mL, 20.0 Grams Protein

NDC Number:
0944-2700-07
300mL, 30.0 Grams Protein
Baxalta US Inc., a subsidiary of Shire Pharmaceuticals, a Takeda Company 1-866-888-0660 In April 2019, Baxalta US Inc., reported that GAMMAGARD LIQUID® Immune Globulin Infusion (Human) was available, but that patient shipping schedules could be impacted as continued high demand exceeded production plans and available inventory. Resolved: August 2021
Zoster Vaccine Recombinant, Adjuvanted
SHINGRIX®

NDC Number:
58160-819-12

1 dose

NDC Number
58160-823-11

10 doses
GlaxoSmithKline Biologicals 1-800-772-9292 In May 2018 GlaxoSmithKline Biologicals reported that customers may experience shipping delays and back-orders for SHINGRIX® when demand exceeded production plans and available inventory, but that resupply was expected to be continuous and expedited in response to demand.

In January 2020 GlaxoSmithKline Biologicals reported that supply of SHINGRIX® would steadily increase for the U.S. market, but due to continued high levels of demand volume and timing of shipments would be actively managed in order to ensure distribution on a consistent and predictable schedule across customer channels.
Resolved:
June 2021
Yellow Fever Vaccine
YF-VAX®

NDC Number:
49281-915-01
Vial, 1 Dose (5 per package)

NDC Number:
49281-915-05
Vial, 5 Dose with 3mL vial of diluent
Sanofi Pasteur Inc. 1-800-VACCINE
(1-800-822-2463)
In April 2016 Sanofi Pasteur Inc. reported there was a limited supply of YF-VAX®.

In July 2017 Sanofi Pasteur Inc. reported that YF-VAX® was unavailable to order.

Sanofi Pasteur worked with FDA to make another yellow fever vaccine available in the U.S. during the time period that YF-VAX® was unavailable to order.
Resolved: April 2021
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Adult formulation (10 mcg/1mL), vials and syringes

Suspension for intramuscular injection

NDC Number:
0006-4995-00
1 Vial, Single-use in 1 Carton

NDC Number:
0006-4995-41
10 Vials, Single-use in 1 Carton

NDC Number:
0006-4094-02
10 Syringes, Single-use in 1 Carton

NDC Number:
0006-4094-09
6 Syringes, Single-use in 1 Carton
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. 1-800-NSC-MERCK
(1-800-672-6372)
In May 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Adult formulation was unavailable due to increased global demand for this product.

In July 2020 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Adult formulation would be available in some packaging configurations, but shipping delays may occur.
Resolved:
August 2020
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Dialysis formulation (40 mcg/mL), vials

NDC Number:
0006-4992-00
1 vial, Single-use in 1 Carton

Suspension for intramuscular injection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. 1-800-NSC-MERCK
(1-800-672-6372)
In April 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Dialysis formulation was unavailable due to increased global demand for this product. Resolved:
July 2020
Rabies Immune Globulin (Human)
Imogam®

NDC Number:
49281-0190-20
2 mL vial

NDC Number:
49281-0190-10
10 mL vial
Sanofi Pasteur SA 1-800-VACCINE
(1-800-822-2463)
In August 2019 Sanofi Pasteur SA reported a limited supply of Rabies Immune Globulin (Human) Imogam®. Supply of Imogam® was only being shipped directly to customers who had a patient with current suspected rabies exposure requiring immediate post-exposure prophylaxis.

This measure was necessary to responsibly manage the limited supply of rabies immune globulin in the United States.
Resolved:
May 2020
Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Pediatric/Adolescent formulation (5 mcg/0.5mL),
vials and syringes

NDC Number:
0006-4981-00
10 Vials, Single-use in 1 Carton

NDC Number:
0006-4093-02
10 Syringes, Single-use in 1 Carton

NDC Number:
0006-4093-09
6 Syringes, Single-use in 1 Carton
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc 1-800-NSC-MERCK
(1-800-672-6372)
In August 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation was unavailable.

In May 2018 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation would be unavailable for order but a very limited supply would be allocated to the Centers for Disease Control and Prevention (CDC) to ensure utilization consistent with their clinical guidance.

In February 2019 and September 2019 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation would be available in limited supply, but that supply would be allocated to the Centers for Disease Control and Prevention (CDC) to ensure utilization consistent with their clinical guidance.
Resolved:
March 2020
Immune Globulin Subcutaneous (Human), 20% Solution
Cuvitru®

NDC Number:
0944-2850-01
5mL, 1.0 Grams Protein

NDC Number:
0944-2850-03
10 mL, 2.0 Grams Protein

NDC Number:
0944-2850-05
20 mL, 4.0 Grams Protein

NDC Number:
0944-2850-07
40 mL, 8.0 Grams Protein
Baxalta US, Inc. 1-800-828-2088 In December 2018 Baxalta US, Inc., a subsidiary of Shire plc. reported that Immune Globulin Subcutaneous (Human), 20% Solution Cuvitru® was available in limited quantity and patient shipping schedule would be impacted when demand exceeded production plans and available inventory. Resolved:
October 2019
Tuberculin, Purified Protein Derivative
Aplisol®

NDC Number:
42023-104-01
1mL (10 tests) – multiple dose vial

NDC Number:
42023-104-05
5mL (50 tests) – multiple dose vial
Par Pharmaceutical Companies, Inc. 1-800-828-9393 In June 2019 Par Pharmaceutical Companies, Inc. reported that Tuberculin, Purified Protein Derivative Aplisol® was available but was expected to be in limited supply through 2019.

More information may be found here: https://emergency.cdc.gov/han/han00420.asp
Resolved:
August 2019
C1-Esterase Inhibitor (Human)
Cinryze®

NDC Number:
42227-081-05

1 Vial, Single-use in 1 Carton

NDC Number:
42227-081-01

5 mL in 1 Vial, Single-use
ViroPharma Biologics, Inc., a subsidiary of Shire Pharmaceuticals 1-866-888-0660 In April 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was available, but patient shipping schedule may be impacted if demand exceeded production plans and available inventory.

In September 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was unavailable.

In November 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was available, but patient shipping schedule may be impacted if demand exceeded production plans and available inventory.
Resolved: July 2018
Immune Globulin Intravenous (Human)
Gammaplex®

NDC Number:
64208-8234

Gammaplex 5% Liquid

NDC Number:
64208-8235

Gammaplex 10% Liquid
Bio Products Laboratory 1-844-4BPLUSA (1-844-427-5872) In December 2017 Bio Products Laboratory (BPL), the manufacturer of Gammaplex®, reported a short-term supply disruption and immediate shortage of Gammaplex 5% Liquid and Gammaplex 10% Liquid. Resolved: May 2018
Tetanus and Diphtheria Toxoids Adsorbed
TENIVAC® NDC Number:
49281-215-10

.5 mL in 1 VIAL, Single Dose (10 per package)

NDC Number:
49281-215-15

.5 mL in 1 SYRINGE (10 per package)
Sanofi Pasteur Limited 1-800-VACCINE
(1-800-822-2463)
In November 2016 Sanofi Pasteur Limited reported that TENIVAC® vaccine (Tetanus and Diphtheria Toxoids Adsorbed) was temporarily unavailable. Resolved: August 2017
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Pentacel®

NDC Number:
49281-0510-05

Vial, 1 Dose (5 per package)
Sanofi Pasteur Limited 1-800-VACCINE
(1-800-822-2463)
In December 2015 Sanofi Pasteur Limited reported that they were experiencing a manufacturing delay for Pentacel® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.

As a result, Pentacel® was available under supply limitations in order to help manage inventory.
Resolved: December 2016

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