Vaccines, Blood & 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

ProductManufacturerManufacturer Contact InformationAdditional InformationResolved Date
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 Pharmaceuticals1-866-888-0660In 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 Laboratory1-844-4BPLUSA (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 Limited1-800-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 Limited1-800-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

Rabies Immune Globulin (Human)
Imogam®

NDC Number:
49281-0190-20

2 mL vial

NDC Number:
49281-0190-10

10 mL vial

Sanofi Pasteur SA1-800-VACCINE
(1-800-822-2463)

In January 2015 Sanofi Pasteur SA reported a limited supply of Rabies Immune Globulin (Human) Imogam®. Supply of Imogam® was only being shipped directly to customers as needed for use with patients that had a documented exposure suspicious for rabies that required post-exposure prophylaxis.

This measure was necessary to responsibly manage the limited supply of rabies immune globulin in the United States.

Resolved: June 2016

Antivenin (Latrodectus Mactans)
Black Widow Spider Antivenin (Equine Origin)

NDC Number:
0006-5424-02

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1-800-NSC-MERCK
(1-800-672-6372)
In January 2009 Merck & Co., Inc. reported that they were temporarily limiting distribution of Antivenin (Latrodectus Mactans) to cases of confirmed black widow spider bites.Resolved: January 2016

BCG Live (Intravesical)
TICE® BCG

NDC Number:
00052-0602-02

50 mg lyophilized powder

Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc.

1-800-NSC-MERCK
(1-800-672-6372)
Or visit:

http://www.merck.com/product/oncology/home.html

In May 2012 Merck & Co., Inc. reported that they were experiencing delays in the availability of BCG Live (Intravesical) TICE® BCG because of an increased demand for this product.

In order to help manage inventory product was placed on allocation as needed.

Resolved: October 2015
Hepatitis B Immune Globulin (Human)
HyperHEP B® S/D

NDC Number:
13533-0636-05

5 mL vial
Grifols Therapeutics, Inc.1-800-243-4153In August 2014 Grifols Therapeutics, Inc. reported that they had a limited supply of 5 mL vials of Hepatitis B Immune Globulin (Human) HyperHEP B® S/D.

However, there was an ample supply of HyperHEP B® S/D in the 1 mL syringe (NDC Number: 13533-636-02) and the 0.5 mL syringe (NDC Number: 13533-636-03) presentations.
Resolved: October 2014
Diptheria 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 Limited1-800-VACCINE (1-800-822-2463)In April 2012 Sanofi Pasteur Limited reported that they anticipated a supply interruption in the United States for Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel®.

In October 2013 Sanofi Pasteur Limited reported that Pentacel® was available under supply limitations in order to help manage inventory.
Resolved: July 2014
Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
Vaccine (DTaP)
DAPTACEL®

NDC Number:
49281-286-10

Vial, 1 Dose (10 per package)
Sanofi Pasteur Limited1-800-VACCINE (1-800-822-2463)In April 2012 Sanofi Pasteur Limited reported that Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed Vaccine (DTaP) DAPTACEL® was available under supply limitations in order to help manage inventory.Resolved: July 2014
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)
Adacel®

NDC Number:
49281-400-05

Vial, 1 Dose (5 per package)

NDC Number:
49281-400-10

Vial, 1 Dose (10 per package)

NDC Number:
49281-400-15

Syringe, 1 Dose (5 per package)
Sanofi Pasteur Limited1-800-VACCINE (1-800-822-2463)In August 2013 Sanofi Pasteur Limited reported that Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) Adacel® was temporarily unavailable.

In October 2013 Sanofi Pasteur Limited reported that Adacel® was under supply limitations in order to help manage inventory.

Resolved: July 2014
Tuberculin, Purified Protein Derivative
Tubersol®

NDC Number:
49281-0752-21

5 tuberculin units/0.1 mL, 1 mL (10 tests), multiple dose vial

NDC Number:
49281-0752-22

5 tuberculin units/0.1 mL, 5 mL (50 tests), multiple dose vial
Sanofi Pasteur Limited1-800-VACCINE (1-800-822-2463)In March 2013 Sanofi Pasteur Limited reported that they were experiencing a temporary delay in the availability of Tuberculin, Purified Protein Derivative Tubersol®.

In October 2013 Sanofi Pasteur Limited reported that Tuberculin, Purified Protein Derivative Tubersol® was available under supply limitations in order to help manage inventory.

Resolved: July 2014
Rabies Vaccine
RabAvert®

NDC Number:
63851-0501-01

1 mL vial
Novartis Vaccines and Diagnostics, Inc.1-617-871-7000In September 2011 Novartis Vaccines and Diagnostics, Inc. reported a limited supply of Rabies Vaccine RabAvert®. Supply of RabAvert® was available in the wholesaler/distributor channels in limited quantities and also available directly from Novartis to physicians not able to order through a wholesaler/distributor for use with patients for post-exposure prophylaxis.Resolved: June 2014
Tuberculin, Purified Protein Derivative
Aplisol®

NDC Number:
42023-0104-01

5 tuberculin units/0.1 mL, 1 mL (10 tests), multiple dose vial

NDC Number:
42023-0104-05

5 tuberculin units/0.1 mL, 5 mL (50 tests), multiple dose vial
JHP Pharmaceuticals, LLC1-877-547-4547In April 2013 JHP Pharmaceuticals, LLC reported that Tuberculin, Purified Protein Derivative Aplisol® was on allocation and was available in restricted quantity.

There was an increased demand for this product.

Resolved: May 2014
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 December 2013 Sanofi Pasteur Inc. reported a limited supply of Yellow Fever Vaccine YF-VAX®. Yellow Fever Vaccine was available under supply limitations in order to help manage inventory.Resolved: May 2014

 

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Biological Product Shortages

Page Last Updated: 03/20/2019
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