Vaccines, Blood & Biologics

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.

ProductManufacturer and Manufacturer Contact InformationProduct Availability and Estimated Shortage Duration (when known)Shortage Reason (per FDASIA)*Additional InformationDate
Antivenin (Latrodectus Mactans)
Black Widow Spider Antivenin (Equine Origin)

NDC Number:
Merck & Co., Inc.
For questions, please call Merck customer service at:


Merck & Co., Inc. is temporarily limiting distribution of Antivenin (Latrodectus Mactans) to cases of confirmed black widow spider bites.Shortage of an active ingredientHow to obtain products for patients with confirmed black widow spider bites:

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


Onset: January 2009

Updated: February 2013


BCG Live (Intravesical)

NDC Number:

81 mg lyophilized powder
Sanofi Pasteur, Ltd.
For questions, please call Sanofi customer service at:
TheraCys® BCG is currently unavailable.Requirements related to complying with good manufacturing practices Onset:
May 2012


Rabies Immune Globulin (Human) Imogam®

NDC Number:

2 mL vial

NDC Number:

10 mL vial
Sanofi Pasteur SA
For questions, please call Sanofi Pasteur customer service at: 1-800-VACCINE (1-800-822-2463)

Sanofi Pasteur SA currently has a limited supply of Rabies Immune Globulin (Human) Imogam®

Currently, Imogam® is only being shipped directly to customers as needed for use with patients that have a documented exposure suspicious for rabies that require post-exposure prophylaxis.

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


How to obtain products for patients with urgent need:

Access post-exposure information via link on www.vaccineshoppe.comdisclaimer icon home page.

Please fill out a Rabies Post-exposure Form in its entirety and fax it to Sanofi Pasteur at 1-877-287-9391 (Attn: Sanofi Pasteur Customer Service).

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

Onset: January 2015


Immune Globulin Intravenous (Human)Multiple manufacturersNot applicableOther (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: 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

Biological Product Shortages

Page Last Updated: 11/05/2015
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