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 at the bottom of the page 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
Albumin (Human)-kjda ALBUMINEX 5%® 12.5g in 250mL NDC Number: 64208-2510-2 25g in 500mL NDC Number: 64208-2510-6	Bio Products Laboratory Limited For questions, please contact BPL Ltd. customer service at: 1-844-4BPLUSA (1-844-427-5872)	ALBUMINEX 5%® Albumin (Human)-kjda is currently available in limited supply.	Demand increase in the drug or biological product Other	Bio Products Laboratory Limited (BPL Ltd.) anticipates that due to high demand and manufacturing schedule ALBUMINEX 5%® Albumin (Human)-kjda 250ml and 500ml vials may intermittently be on backorder. BPL Ltd. anticipates resupply to be continuous and expedited but customers may experience intermittent availability when manufacturing delays occur. There continues to be ample supply of ALBUMINEX 25%® available through the exclusive distributor of ALBUMINEX®, FFF Enterprises, Inc. To check availability and to order ALBUMINEX®, please contact FFF Enterprises directly at: 1-800-843-7477 or: Albumin (fffenterprises.com)	Onset: November 2022 Updated: October 2024 Ongoing
Immune Globulin Intravenous (Human) Gammaplex® NDC Number: 64208-8234 Gammaplex 5% Liquid NDC Number: 64208-8235 Gammaplex 10% Liquid	Bio Products Laboratory Limited For questions, please contact BPL Ltd. customer service at: 1-844-4BPLUSA (1-844-427-5872)	Gammaplex® Immune Globulin Intravenous (Human) is currently available but due to continued high demand and manufacturing schedule, there is a limited supply of this product, which is presently being allocated to a limited number of customers.	Demand increase in the drug or biological product Other	For questions, please contact BPL Ltd. customer service at: 1-844-4BPLUSA (1-844-427-5872)	Onset: October 2018 Updated: October 2024 Ongoing
plasminogen, human-tvmh RYPLAZIM® NDC Number: 70573-099-01 68.8 mg/vial	Manufactured by: Prometic Biotherapeutics, Inc. Distributed by Kedrion Biopharma, Inc. For questions, please call customer service at: 1-855-353-7466	RYPLAZIM® plasminogen, human-tvmh is currently in allocation to guarantee patient continuity of care. It is expected that the supply situation will normalize toward the end of the current year.	Other	To check product availability or if you have any medical/medical information-related inquiries, please contact Kedrion Biopharma at: US_Medicalinfo@kedrion.com Additional information may also be found here: https://www.ryplazim.com/healthcare-provider/	Onset: July 2023 Updated: October 2024 Ongoing
10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) NDC Number: 0409-7418-03 10% 500 mL Flexible Container	Manufactured by: Hospira, Inc. For questions, please call customer service at: 1-844-646-4398	At this time 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) is not available.	Shortage of an active ingredient Other	To check product availability, please contact Pfizer Hospital at: 1-844-646-4398 Additional information may also be found here: https://www.pfizerhospitalus.com/products/dextran-40-dextrose https://www.pfizerhospitalus.com/resources	Onset: June 2024 Ongoing
Rho(D) Immune Globulin (Human) RhoGAM NDC Numbers: 0562-7805-01 RhoGAM Ultra-Filtered PLUS (300 μg) (1500 IU) – Carton of 1 syringe 0562-7805-05 RhoGAM Ultra-Filtered PLUS (300 μg) (1500 IU) – Carton of 5 syringes 0562-7805-25 RhoGAM Ultra-Filtered PLUS (300 μg) (1500 IU) – Carton of 25 syringes	Kedrion Biopharma Inc. For questions, please call customer service at: 1-855-3KDRION (1-855-353-7466)	At this time Rho(D) Immune Globulin (Human) RhoGAM is experiencing a reduction of supply. This reduction of supply is expected to last throughout 2024	Shortage of an active ingredient Other	This is a multifactorial situation affecting supply and includes the shortage of an active ingredient, manufacturing issues and plant maintenance requirements. To check product availability please contact Kedrion Biopharma at US_CustomerService@kedrion.com or if you have any medical/medical information-related inquiries, please contact US_Medicalinfo@kedrion.com Additional information may also be found at www.Rhogam.com	Onset: December 2023 Ongoing
Blood Pack Units with CPDA-1 and RS-2000 Whole Blood Leukoreduction Filter: Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) with an Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction Filter and Fenwal HighFlo Needle, Double NDC Number: 0942-6320-02 Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) with an Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction Filter and Fenwal HighFlo Needle, Double NDC Number: 0942-6308-02 Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) with an Integral Sepacell RS-2000 Whole Blood Leukocyte Reduction Filter and Fenwal HighFlo Needle, Quadruple NDC Number: 0942-6326-04 Blood-Pack Units with Anticoagulant Citrate Dextrose (ACD) Solution ACD Single BPU 450 mL NDC Number: 0942-9001-01 Blood-Pack Units with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution: CPD Single BPU 450 mL NDC Number: 0942-9292-01 CPD Single BPU 250 mL NDC Number 0942-9201-01 Blood-Pack Units with Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and Adsol Red Cell Preservation Solution Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6504-02 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6505-02 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6506-02 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6507-02 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6508-02 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6514-01 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6515-01 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6516-01 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6517-01 Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit, Transfer Pack Container with Adsol Red Cell Preservation Solution, Integral Fenwal Bioflex RC Red Cell Leukocyte Reduction Filter 500 mL NDC Number: 0942-6518-01 InterSol Solution NDC Number: 0942-9602-12 All solution subassemblies for use in further manufacture of apheresis kits, including: ACD-A, Adsol, Saline – Alyx kits ACD-A, Saline – Amicus Kits	Fenwal, Inc., a subsidiary of Fresenius Kabi AG For questions, please call customer service at: 1-800-3-FENWAL (1-800-333-6925)	Please see additional information.	Shortage of an active ingredient; Delay in shipping of the drug or biological product; Other	Fenwal has informed the FDA that due to manufacturing problems and quality procedures at Fenwal manufacturing facilities, including global supply chain issues related to the lack of some materials and components needed for the manufacturing process, the products listed in this notice may be in short supply and/or shortage until further notice. Shortages of ingredients, components and manufacturing supplies, and release timing issues are intermittent and unpredictable. Product may be placed on allocation as necessary to manage reduced or unavailable supply.	Onset: January 2022 Updated: May 2023 Ongoing
BCG Live (Intravesical) TICE® BCG NDC Number: 00052-0602-02 50 mg lyophilized powder	Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc. For questions, please call customer service at: 1-800-NSC-MERCK 1-800-672-6372	TICE® BCG, BCG Live (Intravesical) is currently available. In order to help manage inventory and to minimize disruption to patient care when demand exceeds production plans and available inventory product will be placed on allocation.	Demand increase in the drug or biological product	Because of increased global demand and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for TICE® BCG for the foreseeable future. To minimize disruption to patient care and address the current imbalance between supply and increased global demand TICE® BCG will be under allocation when demand exceeds production plans and available inventory. Please Note: In the past, Merck has provided preservative-free saline with certain orders of TICE® BCG. Merck is no longer able to provide saline with TICE® BCG and has discontinued the distribution of saline with TICE® BCG. For questions, please call Merck customer service at: 1-800-NSC-MERCK 1-800-672-6372 Or visit http://www.merck.com/product/oncology/home.html	Onset: January 2019 Updated: July 2020 Ongoing
BCG Vaccine NDC Number: 00052-0603-02 50 mg lyophilized powder	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	BCG Vaccine, for tuberculosis prevention is currently unavailable.	Other	Merck is developing a control mechanism to ensure that customer orders being placed for BCG Vaccine, are for tuberculosis prevention. BCG vaccine will remain unavailable until a new ordering process is implemented. For questions, please call Merck customer service at: 1-800-NSC-MERCK (1-800-672-6372) Or visit https://www.merckorders.com	Onset: July 2019 Updated: November 2019 Ongoing

* 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.