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   

Product Manufacturer Manufacturer Contact Information Additional Information Resolved Date
Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Pentacel®
Sanofi Pasteur Limited 1-800-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
NDC Number
49281-0510-05

Vial, 1 Dose (5 per package)
Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
Vaccine (DTaP)
DAPTACEL®
Sanofi Pasteur Limited 1-800-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
NDC Number:
49281-286-10

Vial, 1 Dose (10 per package)
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)   Adacel® Sanofi Pasteur Limited 1-800-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
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)
Tuberculin, Purified Protein Derivative
Tubersol®
Sanofi Pasteur Limited 1-800-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
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
Tuberculin, Purified Protein Derivative
Aplisol®
JHP Pharmaceuticals, LLC 1-877-547-4547 In 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
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
Yellow Fever Vaccine YF-VAX®
NDC Number:
49281-915-01
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
Vial, 1 Dose (5 per package)
NDC Number:
49281-915-05
Vial, 5 Dose with 3mL vial of diluent
Immune Globulin (Human)
GamaSTAN® S/D
Grifols Therapeutics Inc. 1-800-243-4153 In July 2011 Grifols Therapeutics Inc. reported 2-ml vials of GamaSTAN® S/D were available on a limited basis.

In October 2013 Grifols reported that 2-ml vials of GamaSTAN® S/D were on allocation and were available in restricted quantity.

Resolved: February 2014
NDC Number:
13533-635-02

2 mL vial (10 pack)
NDC Number:
13533-635-04

2 mL vial
Rabies Immune Globulin (Human)
Imogam®
Sanofi Pasteur SA 1-800-VACCINE
(1-800-822-2463)
In March 2013 Sanofi Pasteur SA reported a limited supply of Rabies Immune Globulin (Human) Imogam®.  It was only being shipped directly to customers as needed for use with patients that had a documented exposure to rabies. Resolved:
August 2013
NDC Number:
49281-0190-20

2 mL vial
NDC Number:
49281-0190-10

10 mL vial
Rabies Vaccine
IMOVAX®
Sanofi Pasteur SA 1-800-VACCINE
(1-800-822-2463)
In March 2013 Sanofi Pasteur SA reported a limited supply of Rabies Vaccine IMOVAX®. It was only being shipped directly to customers as needed for use with patients that had a documented exposure to rabies. Resolved: May 2013
NDC Number:
49281-0250-51
Hepatitis A Vaccine
VAQTA®
Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)
In February 2008 Merck & Co., Inc. reported that:

VAQTA® (Hepatitis A Vaccine, Inactivated) Adult Formulation 1ml vials were unavailable 

 But

VAQTA® (Hepatitis A Vaccine, Inactivated) Adult Formulation 1ml prefilled syringes were available
Resolved: February 2013
NDC Number:
0006-4841-00

1.0 mL single dose vial
NDC Number:
0006-4841-41

1 mL vial (10 single dose vials
Measles, Mumps, Rubella and Varicella Virus Vaccine Live
ProQuad®

 

Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)
In June 2007 Merck & Co., Inc. reported that ProQuad® was unavailable. Resolved: October 2012
NDC Number:
0006-4999-00

0.5 mL 10 dose vials
Zoster Vaccine Live
Zostavax®

 

Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)
In July 2008 Merck & Co., Inc. reported shipping delays for Zostavax® (Zoster Vaccine Live) with backorders of 3 to 5 weeks. Resolved: December 2011
NDC Number:
0006-4963-00

0.65 mL single dose vial
NDC Number:
0006-4963-41

0.65 mL 10 dose vials
Hepatitis B Vaccine
Recombivax HB®
Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)

 

In January 2009 Merck & Co., Inc. reported a supply interruption in the United States for the adult formulation of Hepatitis B vaccine, Recombivax HB®. This included vials, syringes and dialysis formulations.

Pediatric formulations were not affected and were sufficient to meet anticipated demand. 

Resolved:
August 2011
NDC Number:
0006-4980-00

0.5 mL single dose vial
NDC Number:
0006-4981-00

0.5 mL 10 dose vials
NDC Number:
0006-4093-09

0.5 mL 6 dose syringes
NDC Number:
0006-4995-00

1.0 mL single dose vial
NDC Number:
0006-4094-09

1.0 mL 6 dose syringes
NDC Number:
0006-4992-00

1.0 mL single dose vial
Immune Globulin (Human)
GamaSTAN® S/D

 

Talecris Biotherapeutics, Inc. 1-800-243-4153 In January 2010 Talecris Biotherapeutics, Inc. reported 2-ml vials of GamaSTAN® S/D were in temporary short supply. Resolved: July 2011
NDC Number:
13533-635-02

2 mL vial (10 pack)
NDC Number:
13533-635-04

2 mL vial
Haemophilus influenza Type b (Hib) Conjugate
Comvax®
Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)

 

In December 2007 Merck & Co., Inc. reported that Comvax® was not available. Resolved: August 2010
NDC Number:
0006-4898-00

0.5 mL 10 dose vials
Immune Globulin (Human)
GamaSTAN® S/D
Talecris Biotherapeutics, Inc. 1-800-243-4153 In April 2009 Talecris Biotherapeutics, Inc. reported 10-ml vials of GamaSTAN® S/D were in temporary short supply. Resolved: March 2010
NDC Number:
13533-635-10

10 mL vial (10 pack)
NDC Number:
13533-635-12

10 mL vial

 

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Biological Product Shortages

Page Last Updated: 10/01/2014
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