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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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

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®
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
NDC Number:
49281-915-01

 
Vial, 1 Dose (5 per package)
NDC Number:
49281-915-05

 
Vial, 5 Dose with 3mL vial of diluent
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

 

 

Contact FDA

240-402-8380
Biological Product Shortages