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

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
Immune Globulin (Human)
GamaSTAN® S/D

NDC Number:
13533-635-02

2 mL vial (10 pack)

NDC Number:
13533-635-04

2 mL vial
Grifols Therapeutics Inc.1-800-243-4153In 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
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 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
Rabies Vaccine
IMOVAX®

NDC Number:
49281-0250-51
Sanofi Pasteur SA1-800-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
Hepatitis A Vaccine
VAQTA®

NDC Number:
0006-4841-00

1.0 mL single dose vial

NDC Number:
0006-4841-41

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

NDC Number:
0006-4999-00

0.5 mL 10 dose vials
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
Zoster Vaccine Live
Zostavax®

NDC Number:
0006-4963-00

0.65 mL single dose vial

NDC Number:
0006-4963-41

0.65 mL 10 dose vials
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
Hepatitis B Vaccine
Recombivax HB®

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
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
Immune Globulin (Human)
GamaSTAN® S/D

NDC Number:
13533-635-02

2 mL vial (10 pack)

NDC Number:
13533-635-04

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

 

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Biological Product Shortages

Page Last Updated: 06/13/2016
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