• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

CBER-Regulated Products: Current Shortages

The following table identifies current shortages of CBER-regulated products. The information contained in this table is generally provided to CBER by the manufacturer of the CBER-regulated product that is in shortage. CBER is committed to ensuring that the information in the table is current, and works closely with the manufacturer to obtain accurate information.

Please refer to the Resources for You box to the left for a complete listing of all CBER approved, licensed, and cleared products, as well as CDC's recommended immunization schedules for adult and children.

Additional information regarding possible causes for CBER-regulated product shortages is provided on CBER-Regulated Products: Possible Causes of Shortages Page.

Product

Manufacturer
And
Manufacturer
Contact Information

Product Availability
and
Estimated Shortage Duration
(when known)

Shortage Reason
(per FDASIA)*

Additional Information

Date

Hepatitis B Immune Globulin (Human)

HyperHEP B® S/D

Grifols Therapeutics, Inc.
For questions, please call Grifols customer service at:

1-800-243-4153

Or email at: customer.service@grifols.com

Currently Grifols Therapeutics, Inc. has a limited supply of 5 mL vials of Hepatitis B Immune Globulin (Human) HyperHEP B® S/D.  

However, there is 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.

Other

How to obtain products for patients with urgent need:

Healthcare providers may contact Grifols Therapeutics Inc., directly at:

1-800-243-4153

Onset:

August 2014 Ongoing

NDC Number:
13533-0636-05

5 mL vial

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

Merck & Co., Inc.
For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)

Merck & Co., Inc. is temporarily limiting distribution of Antivenin (Latrodectus Mactans) to cases of confirmed black widow spider bites.  

Shortage of an active ingredient

How to obtain products for patients with confirmed black widow spider bites:

Healthcare providers may contact Merck & Co., Inc., directly at:

1-800-NSC-MERCK
(1-800-672-6372)

Onset: January 2009

 

Updated: February 2013
 

 

Ongoing

NDC Number:
00006-4084-00

BCG Live (Intravesical)
TheraCys®

Sanofi Pasteur, Ltd.
For questions, please call Sanofi customer service at:
1-800-VACCINE
 
(1-800-822-2463)  

TheraCys® BCG is currently unavailable.

Requirements related to complying with good manufacturing practices

Please see information for: BCG Live (Intravesical)
TICE® BCG
below.

Onset:
May 2012
 

 

Ongoing

NDC Number:
49281-0880-03

81 mg lyophilized powder

BCG Live (Intravesical)
TICE® BCG

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

For questions, please call Merck customer service at:
1-800-NSC-MERCK
(1-800-672-6372)

TICE® BCG is not available.

Product may be available beginning in October 2014.

Shortage of an active ingredient and demand increase for the drug.

Manufacturing issue in conjunction with an increased demand for this product.

Please check with your physician, wholesaler, or call Merck directly for product availability.
1-800-NSC-MERCK
(1-800-672-6372)

Please see information for: BCG Live (Intravesical)
TheraCys®
above.

Onset:
May 2012

Updated: August 2014

Ongoing

NDC Number:
00052-0602-02

50 mg lyophilized powder

Rabies Vaccine
RabAvert®

Novartis Vaccines and Diagnostics, Inc.
For questions, please call Novartis customer service at:
 1-617-871-7000
Information can also be found at: RabAvert Rabies Vaccine Supply Limitation

Novartis Vaccines and Diagnostics, Inc. currently has a limited supply of Rabies Vaccine RabAvert®

Other

How to obtain products for patients with urgent need:
 
At this time there is a normal supply of RabAvert® in the wholesaler/distributor channels.

However, Novartis does have a limited supply of RabAvert® in inventory and can make product available to physicians who are not able to order through a wholesaler/distributor and who need RabAvert® for post-exposure prophylaxis.

Information can be found at:
RabAvert Rabies Vaccine Supply Limitationdisclaimer icon9

Onset:
September 2011
 

 

Ongoing

NDC Number:
63851-0501-01

1 mL vial

Immune Globulin Intravenous (Human)

Multiple manufacturers

Not applicable

Other (No evidence of shortages, but CBER monitors for possible fluidity in product supply/demand)

Since the 1990’s, the FDA, along with other HHS agencies, has periodically received reports from stakeholders, patients, and health care providers regarding difficulty in obtaining Immune Globulin Intravenous (IGIV) products. From discussions with manufacturers, distributors, providers, and consumers, it is clear that availability and treatment patterns have shifted; but we have not found clear evidence that there is a shortage. This is a multi-faceted and fluid situation. 

If you have any difficulty in obtaining IGIV and/or have additional information concerning the availability of IGIV please contact CBER at:
CBERshortage@fda.hhs.gov or (240) 402-8380.  

Onset: Not applicable
 

 

Updated: June 2012
 

 

Being monitored
 

 * FDASIA added several new, drug-shortage related sections to the FD&C Act, including section 506E. Section 506E of the FD&C Act further requires FDA to include on the shortages list the reason for the shortage, choosing from the following categories:

  • Requirements relating to complying with current good manufacturing practices (CGMP);
  • Regulatory delay;
  • Shortage of an active ingredient;
  • Shortage of an inactive ingredient component;
  • Discontinuation of the manufacture of the drug or biological product;
  • Delay in shipping of the drug or biological product;
  • Demand increase in the drug or biological product; or
  • Other.

 

 

Contact FDA

240-402-8380
Biological Product Shortages