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|
|Immune Globulin Subcutaneous (Human), 20% Solution
5mL, 1.0 Grams Protein
10 mL, 2.0 Grams Protein
20 mL, 4.0 Grams Protein
40 mL, 8.0 Grams Protein
|Baxalta US, Inc.||1-800-828-2088||In December 2018 Baxalta US, Inc., a subsidiary of Shire plc. reported that Immune Globulin Subcutaneous (Human), 20% Solution Cuvitru® was available in limited quantity and patient shipping schedule would be impacted when demand exceeded production plans and available inventory.||Resolved:
|Tuberculin, Purified Protein Derivative
1mL (10 tests) – multiple dose vial
5mL (50 tests) – multiple dose vial
|Par Pharmaceutical Companies, Inc.||1-800-828-9393||In June 2019 Par Pharmaceutical Companies, Inc. reported that Tuberculin, Purified Protein Derivative Aplisol® was available but was expected to be in limited supply through 2019.
More information may be found here: https://emergency.cdc.gov/han/han00420.asp
|C1-Esterase Inhibitor (Human)
1 Vial, Single-use in 1 Carton
5 mL in 1 Vial, Single-use
|ViroPharma Biologics, Inc., a subsidiary of Shire Pharmaceuticals||1-866-888-0660||In April 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was available, but patient shipping schedule may be impacted if demand exceeded production plans and available inventory.
In September 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was unavailable.
In November 2017 Shire Pharmaceuticals reported C1-Esterase Inhibitor (Human) Cinryze® was available, but patient shipping schedule may be impacted if demand exceeded production plans and available inventory.
|Resolved: July 2018|
|Immune Globulin Intravenous (Human)
Gammaplex 5% Liquid
Gammaplex 10% Liquid
|Bio Products Laboratory||1-844-4BPLUSA (1-844-427-5872)||In December 2017 Bio Products Laboratory (BPL), the manufacturer of Gammaplex®, reported a short-term supply disruption and immediate shortage of Gammaplex 5% Liquid and Gammaplex 10% Liquid.||Resolved: May 2018|
|Tetanus and Diphtheria Toxoids Adsorbed
TENIVAC® NDC Number:
.5 mL in 1 VIAL, Single Dose (10 per package)
.5 mL in 1 SYRINGE (10 per package)
|Sanofi Pasteur Limited||1-800-VACCINE
|In November 2016 Sanofi Pasteur Limited reported that TENIVAC® vaccine (Tetanus and Diphtheria Toxoids Adsorbed) was temporarily unavailable.||Resolved: August 2017|
|Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Vial, 1 Dose (5 per package)
|Sanofi Pasteur Limited||1-800-VACCINE
|In December 2015 Sanofi Pasteur Limited reported that they were experiencing a manufacturing delay for Pentacel® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.
As a result, Pentacel® was available under supply limitations in order to help manage inventory.
|Resolved: December 2016|
|Rabies Immune Globulin (Human)
2 mL vial
10 mL vial
|Sanofi Pasteur SA||1-800-VACCINE
|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)
|Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.||1-800-NSC-MERCK
|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)
50 mg lyophilized powder
|Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc.||1-800-NSC-MERCK
|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
5 mL vial
|Grifols Therapeutics, Inc.||1-800-243-4153||In 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|
Resources For You
- Complete List of Licensed Products and Establishments
- Vaccines Licensed for Use in the United States
- Complete List of Currently Approved NDA and ANDA Application Submissions
- Complete List of Currently Approved Premarket Approvals (PMAs)
- Complete List of Substantially Equivalent 510(k) Device Applications
- CDC's Recommended Immunization Schedules for Adults and Children
- Office of Compliance and Biologics Quality (OCBQ)