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.

Product Manufacturer and Manufacturer Contact Information Product Availability and Estimated Shortage Duration (when known) Shortage Reason (per FDASIA)* Additional Information Date
Anticoagulant Sodium Citrate Solution

NDC Number:
0942-9505-10
250 mL

Fenwal, Inc., a subsidiary of Fresenius Kabi USA, LLC.

For questions, please call customer service at: 1-800-3-FENWAL
(1-800-333-6925)

Fenwal Anticoagulant Sodium Citrate Solution 250 mL is in short supply and is being allocated.

This measure is necessary to responsibly manage the limited supply of Anticoagulant Sodium Citrate Solution until supply once again meets demand.

Other

Demand exceeding production and available inventory is causing a short supply situation.

Please check with your wholesaler, or call Fenwal, Inc. directly for product availability.

1-800-3-FENWAL
(1-800-333-6925)

Onset:
May 2017

Ongoing

Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB®

Adult formulation only, vials and syringes

NDC Number:
0006-4995-00
1 Vial, Single-use in 1 Carton

NDC Number:
0006-4995-41
10 Vials, Single-use in 1 Carton

NDC Number:
0006-4094-02
10 Syringes, Single-use in 1 Carton
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.

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

Currently, RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) adult formulation is unavailable.

It is anticipated that the product will become available in the third quarter of 2018.

Demand increase in the drug or biological product

There is an increased global 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)

Onset: May 2017

Ongoing

C1-Esterase Inhibitor (Human)
Cinryze®

NDC Number:
42227-081-05

1 Vial, Single-use in 1 Carton

NDC Number:
42227-081-01

5 mL in 1 Vial, Single-use
ViroPharma Biologics, Inc., a subsidiary of Shire Pharmaceuticals.

For questions, please call Shire customer service at: 1-866-888-0660

Cinryze® C1-Esterase Inhibitor (Human) is currently available.

Patient shipping schedule may be impacted if demand exceeds production plans and available inventory.

Demand increase in the drug or biological product Please check with your physician, pharmacy, or call Shire Pharmaceuticals directly at 1-866-888-0660, option 1 and then option 4 for product availability.

Onset: April 2017

Ongoing

Tetanus and Diphtheria Toxoids Adsorbed
TENIVAC®

NDC Number:
49281-215-10

.5 mL in 1 VIAL, Single Dose (10 per package)

NDC Number:
49281-215-15

.5 mL in 1 SYRINGE (10 per package)
Sanofi Pasteur Limited

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

Currently, TENIVAC® vaccine (Tetanus and Diphtheria Toxoids Adsorbed) is temporarily unavailable.

It is anticipated that the product will become available in the second half of 2017.

Other Additional information from Sanofi Pasteur can be found at: https://www.vaccineshoppe.comdisclaimer icon

Onset: November 2016

Ongoing

Venoms, Honey Bee Venom

Venoms, Mixed Vespid Venom Protein

Venoms, Wasp Venom Protein

Venoms, White Faced Hornet Venom Protein

Venoms, Yellow Hornet Venom Protein

Venoms, Yellow Jacket Venom Protein

Pharmalgen®

Venoms, Honey Bee Venom

NDC Number: 52709-0801-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-0801-2

11 mL in 1 VIAL, MULTI-DOSE

Venoms, Mixed Vespid Venom Protein

NDC Number: 52709-1201-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-1201-2

11 mL in 1 VIAL, MULTI-DOSE

Venoms, Wasp Venom Protein

NDC Number: 52709-1301-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-1301-2

11 mL in 1 VIAL, MULTI-DOSE

Venoms, White Faced Hornet Venom Protein

NDC Number: 52709-1101-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-1101-2

11 mL in 1 VIAL, MULTI-DOSE

Venoms, Yellow Hornet Venom Protein

NDC Number: 52709-1001-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-1001-2

11 mL in 1 VIAL, MULTI-DOSE

Venoms, Yellow Jacket Venom Protein

NDC Number: 52709-0901-1

1.2 mL in 1 VIAL, SINGLE-DOSE

NDC Number: 52709-0901-2

11 mL in 1 VIAL, MULTI-DOSE

ALK - Abello A/S

Customer Service:
1-512-251-0037

For questions concerning patient treatment options or manufacturer conversions, please contact ALK Scientific Services: 1-800-325-7354

Currently ALK - Abello A/S is experiencing a manufacturing delay for the Pharmalgen® (lyophilized allergenic venom extract) products listed below.

Venoms, Honey Bee Venom

Venoms, Mixed Vespid Venom Protein

Venoms, Wasp Venom Protein

Venoms, White Faced Hornet Venom Protein

Venoms, Yellow Hornet Venom Protein

Venoms, Yellow Jacket Venom Protein

As a result, these Pharmalgen® products will be unavailable into 2017.

Other For questions concerning patient treatment options or manufacturer conversions, please contact ALK Scientific Services at 1-800-325-7354.

Onset: November 2016

Ongoing

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

Sanofi Pasteur Inc. has a limited supply of Yellow Fever Vaccine YF-VAX®.

Currently, YF-VAX® is only being provided to customers that have patients who are traveling within 30 days to an area where yellow fever vaccine is required or recommended.

This measure is necessary to responsibly manage the limited supply of YF-VAX® in the United States.

Other

How to obtain products for patients:

Health care providers may no longer place orders for Yellow Fever Vaccine online. Health care providers must call Sanofi Pasteur at 1-800-VACCINE (1-800-822-2463), and speak to a customer service representative. Yellow Fever Vaccine doses will be prioritized to patients who are traveling within 30 days to an area where Yellow Fever Vaccine is required or recommended.

Additional information from Sanofi Pasteur can be found at:

https://www.vaccineshoppe.comdisclaimer icon

Onset: April 2016

Ongoing

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

Biological Product Shortages

Page Last Updated: 06/16/2017
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