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  1. Safety & Availability (Biologics)

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
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
Tuberculin, Purified Protein Derivative
Aplisol®

NDC Number:
42023-104-01
1mL (10 tests) – multiple dose vial

NDC Number:
42023-104-05
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
Resolved:
August 2019
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 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®

NDC Number:
64208-8234

Gammaplex 5% Liquid

NDC Number:
64208-8235

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:
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 1-800-VACCINE
(1-800-822-2463)
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
Pentacel®

NDC Number:
49281-0510-05

Vial, 1 Dose (5 per package)
Sanofi Pasteur Limited 1-800-VACCINE
(1-800-822-2463)
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)
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 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)

NDC Number:
0006-5424-02
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 1-800-NSC-MERCK
(1-800-672-6372)
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)
TICE® BCG

NDC Number:
00052-0602-02

50 mg lyophilized powder
Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc. 1-800-NSC-MERCK
(1-800-672-6372)
Or visit:
http://www.merck.com/product/
oncology/home.html
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

NDC Number:
13533-0636-05

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

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