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  4. CBER-Regulated Products: Current Shortages
  1. Safety & Availability (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 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
10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP)

NDC Number:
0409-7419-03

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 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride 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-sodium-chloride

https://www.pfizerhospitalus.com/resources

Onset: June 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)
WinRho® SDF

NDC Numbers:

49591-330-51
WinRho® SDF Liquid
1500 international units
(300 mcg)
Kamada Ltd.

Please contact Kamada Ltd. at:

Customer Service:
1-833-779-2614

Medical Information:
1-866-916-0077

Or at:

pharmacovigilance@kamada.com

https://www.kamada.com/contact-us/
At this time Rho(D) Immune Globulin (Human) WinRho® SDF is experiencing a reduction of supply due to increase in demand. Demand increase in the drug or biological product Due to high order demands WinRho® SDF 300 mcg/vial dosage is available in limited supply. 

Other WinRho® SDF strengths are available such as 1000 mcg/vial and 3000 mcg/vial.

Please see the Dear Healthcare Professional letter for additional details.

https://www.kamada.com/wp-content/uploads/2024/04/DHCP-letter-WinRho-limited-Availability.pdf

Complete information concerning WinRho® SDF may be found here:

https://www.kamada.com/product/winrho/

Contact Customer Service at 1-833-779-2614 for questions concerning ordering.

Contact the Medical Information Department at 1-866-916-0077 or pharmacovigilance@kamada.com for any questions about the safe and effective use of WinRho® SDF Liquid.  
Onset: February 2024

Updated: April 2024

Ongoing

Coagulation Factor VIIa (Recombinant)
NovoSeven® RT

NDC Number:

0169-7040-01
8 mg per vial (8000 micrograms/vial)

Novo Nordisk Inc.

For information contact: Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536

1-877-NOVO-777

www.NOVOSEVENRT.com
A temporary supply constraint for the 8 mg vial of NovoSeven® RT is expected to last through May 2024. Shortage of an active ingredient Novo Nordisk is experiencing temporary supply constraints of the 8 mg vial of NovoSeven® RT.

Patients can use the 1 mg, 2 mg, and 5 mg vials in combination to make the dose they need in absence of the 8 mg vial.

Patients who have questions about how to make up their dose should consult their healthcare providers.
Onset: February 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
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 provided in a very limited supply and is expected to be out of stock in mid-July 2023. At this time, it is not known when the stockout will be resolved. 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

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
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

For questions, please call 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 Bio Products Laboratory (BPL) anticipates that due to high demand and manufacturing schedule ALBUMINEX 5%® Albumin (Human)-kjda 250ml and 500ml vials will go on backorder between late October 2022 and mid-November 2022. BPL anticipates additional release and availability of ALBUMINEX 5%® 250mL and 500mL vials in the December 2022/January 2023 timeframe.

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

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
Immune Globulin Intravenous (Human)
Gammaplex®

NDC Number:
64208-8234

Gammaplex 5% Liquid

NDC Number:
64208-8235

Gammaplex 10% Liquid
Bio Products Laboratory

For questions, please call BPL 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. Other For questions, please call BPL customer service at:
1-844-4BPLUSA
(1-844-427-5872)
Onset: October 2018

Updated:
August 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.

Resources for You

 
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