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 |
---|---|---|---|---|
Rho(D) Immune Globulin (Human) WinRho® SDF NDC Number: 49591-330-51 WinRho® SDF Liquid 1500 international units (300 mcg) |
Kamada Ltd. | Customer Service: 1-833-779-2614 Medical Information: 1-866-916-0077 |
In February 2024, Kamada Ltd.. reported that due to high order demands WinRho® SDF 300 mcg/vial dosage was not available, but other WinRho® SDF strengths were available in limited supply such as 500 mcg/vial, 1000 mcg/vial and 3000 mcg/vial. In April 2024, Kamada Ltd.. reported that due to high order demands WinRho® SDF 300 mcg/vial dosage was available in limited supply, and other WinRho® SDF strengths were available such as 1000 mcg/vial and 3000 mcg/vial. |
Resolved: August 2024 |
Coagulation Factor VIIa (Recombinant) NovoSeven® RT NDC Number: 0169-7040-01 8 mg per vial (8000 micrograms/vial) |
Novo Nordisk Inc. | 1-877-NOVO-777 1-877-668-6777 |
In February 2024, Novo Nordisk, Inc. reported temporary supply constraints of the 8 mg vial of Coagulation Factor VIIa (Recombinant) NovoSeven® RT. Patients were able to use the 1 mg, 2 mg, and 5 mg vials in combination to make the dose they needed in absence of the 8 mg vial. |
Resolved: July 2024 |
6% Hetastarch in 0.9% Sodium Chloride Injection NDC Number: 0409-7248-03 6 g/100 mL 500 mL Flexible Container |
Hospira, Inc. | 1-844-646-4398 | In January 2022, Hospira, Inc. reported that 6% Hetastarch in 0.9% Sodium Chloride Injection was available but availability may become limited when demand exceeded production plans and available inventory. In July 2023, Hospira, Inc. reported that 6% Hetastarch in 0.9% Sodium Chloride Injection was not available. In December 2023, Hospira, Inc. reported that 6% Hetastarch in 0.9% Sodium Chloride Injection was available but availability may become limited when demand exceeded production plans and available inventory. |
Resolved: April 2024 |
Cholera Vaccine, Live, Oral Vaxchora® NDC Number: 70460-0004-01 |
Emergent Travel Health, Inc. | 1-800-533-5899 Or email at: customercare@ebsi.com |
In May 2021, Emergent Travel Health, Inc. informed the FDA that they had decided to temporarily discontinue the manufacture and distribution of Vaxchora® in the United States due to a significant reduction of international travel caused by the COVID-19 pandemic. Emergent also informed the FDA that they remained committed to travel health and planned to resume the manufacture and distribution of Vaxchora® in the United States once global travel resumed. |
Resolved: May 2023 |
Typhoid Vaccine Live Oral Ty21a VIVOTIF® NDC Number: 69401-000-02 |
Emergent Travel Health, Inc. | 1-800-533-5899 Or email at: customercare@ebsi.com |
In January 2021, Emergent Travel Health, Inc. informed the FDA that they had decided to temporarily discontinue the manufacture and distribution of VIVOTIF® in the United States due to a significant reduction of international travel caused by the COVID-19 pandemic. Emergent also informed the FDA that they remained committed to travel health and planned to resume the manufacture and distribution of VIVOTIF® in the United States once global travel resumed. |
Resolved: June 2022 |
Alpha-1-Proteinase Inhibitor (Human) ZEMAIRA® NDC Number: 0053-7211-01 1000 mg of functionally active A1-PI |
CSL Behring LLC | 1‐800‐504‐5434 Or email at: MedInfoNA@cslbehring.com |
In October 2021, CSL Behring LLC reported that ZEMAIRA® was unavailable from the manufacturer. In November 2021, CSL Behring LLC reported that ZEMAIRA® was available but they had experienced manufacturing delays which could impact supply plans and could create supply disruptions such that customers could experience intermittent availability if manufacturing delays occurred. |
Resolved: February 2022 |
Anticoagulant Sodium Citrate Solution NDC Number: 0942-9505-10 250 mL |
Fenwal, Inc., a subsidiary of Fresenius Kabi USA, LLC. |
1-800-3-FENWAL (1-800-333-6925 ) |
In May 2017, Fenwal, Inc., reported that Anticoagulant Sodium Citrate Solution 250 mL was in short supply and was being allocated. This measure was necessary to responsibly manage the limited supply of Anticoagulant Sodium Citrate Solution until supply once again would meet demand. | Resolved: November 2021 |
Immune Globulin Infusion (Human) GAMMAGARD LIQUID® NDC Number: 0944-2700-02 10mL, 1.0 Grams Protein NDC Number: 0944-2700-03 25mL, 2.5 Grams Protein NDC Number: 0944-2700-04 50mL, 5.0 Grams Protein NDC Number: 0944-2700-05 100mL, 10.0 Grams Protein NDC Number: 0944-2700-06 200mL, 20.0 Grams Protein NDC Number: 0944-2700-07 300mL, 30.0 Grams Protein |
Baxalta US Inc., a subsidiary of Shire Pharmaceuticals, a Takeda Company | 1-866-888-0660 | In April 2019, Baxalta US Inc., reported that GAMMAGARD LIQUID® Immune Globulin Infusion (Human) was available, but that patient shipping schedules could be impacted as continued high demand exceeded production plans and available inventory. | Resolved: August 2021 |
Zoster Vaccine Recombinant, Adjuvanted SHINGRIX® NDC Number: 58160-819-12 1 dose NDC Number 58160-823-11 10 doses |
GlaxoSmithKline Biologicals | 1-800-772-9292 | In May 2018 GlaxoSmithKline Biologicals reported that customers may experience shipping delays and back-orders for SHINGRIX® when demand exceeded production plans and available inventory, but that resupply was expected to be continuous and expedited in response to demand. In January 2020 GlaxoSmithKline Biologicals reported that supply of SHINGRIX® would steadily increase for the U.S. market, but due to continued high levels of demand volume and timing of shipments would be actively managed in order to ensure distribution on a consistent and predictable schedule across customer channels. |
Resolved: June 2021 |
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. | 1-800-VACCINE (1-800-822-2463) |
In April 2016 Sanofi Pasteur Inc. reported there was a limited supply of YF-VAX®. In July 2017 Sanofi Pasteur Inc. reported that YF-VAX® was unavailable to order. Sanofi Pasteur worked with FDA to make another yellow fever vaccine available in the U.S. during the time period that YF-VAX® was unavailable to order. |
Resolved: April 2021 |
Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Adult formulation (10 mcg/1mL), vials and syringes Suspension for intramuscular injection 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 NDC Number: 0006-4094-09 6 Syringes, Single-use in 1 Carton |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. | 1-800-NSC-MERCK (1-800-672-6372) |
In May 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Adult formulation was unavailable due to increased global demand for this product. In July 2020 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Adult formulation would be available in some packaging configurations, but shipping delays may occur. |
Resolved: August 2020 |
Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Dialysis formulation (40 mcg/mL), vials NDC Number: 0006-4992-00 1 vial, Single-use in 1 Carton Suspension for intramuscular injection |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. | 1-800-NSC-MERCK (1-800-672-6372) |
In April 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Dialysis formulation was unavailable due to increased global demand for this product. | Resolved: July 2020 |
Rabies Immune Globulin (Human) Imogam® NDC Number: 49281-0190-20 2 mL vial NDC Number: 49281-0190-10 10 mL vial |
Sanofi Pasteur SA | 1-800-VACCINE (1-800-822-2463) |
In August 2019 Sanofi Pasteur SA reported a limited supply of Rabies Immune Globulin (Human) Imogam®. Supply of Imogam® was only being shipped directly to customers who had a patient with current suspected rabies exposure requiring immediate post-exposure prophylaxis. This measure was necessary to responsibly manage the limited supply of rabies immune globulin in the United States. |
Resolved: May 2020 |
Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation (5 mcg/0.5mL), vials and syringes NDC Number: 0006-4981-00 10 Vials, Single-use in 1 Carton NDC Number: 0006-4093-02 10 Syringes, Single-use in 1 Carton NDC Number: 0006-4093-09 6 Syringes, Single-use in 1 Carton |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc | 1-800-NSC-MERCK (1-800-672-6372) |
In August 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc. reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation was unavailable. In May 2018 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation would be unavailable for order but a very limited supply would be allocated to the Centers for Disease Control and Prevention (CDC) to ensure utilization consistent with their clinical guidance. In February 2019 and September 2019 Merck reported that Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB® Pediatric/Adolescent formulation would be available in limited supply, but that supply would be allocated to the Centers for Disease Control and Prevention (CDC) to ensure utilization consistent with their clinical guidance. |
Resolved: March 2020 |
Immune Globulin Subcutaneous (Human), 20% Solution Cuvitru® NDC Number: 0944-2850-01 5mL, 1.0 Grams Protein NDC Number: 0944-2850-03 10 mL, 2.0 Grams Protein NDC Number: 0944-2850-05 20 mL, 4.0 Grams Protein NDC Number: 0944-2850-07 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: October 2019 |
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)