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Product Safety and Availability
Product Recalls: FDA CBER Recalls
IGIV Recalls and Withdrawals
Listed below are the most recent recalls or withdrawals
of Immune Globulin Intravenous (IGIV) from the U.S. market.
January 28, 2005:
Gammagard S/D
Important Information on variant
Creutzfeldt-Jakob Disease (vCJD): September 29, 2004
1) Statement PDF
2) FAQ about vCJD and Immune Globulin PDF
June 24, 2004:
Gammagard S/D
April 1, 2004: Gammar®-PIV
2003 IGIV Recalls/Withdrawals (CBER Site)
December 22, 2003: Gammar®-PIV
October 3, 2003: Gamimune®
N, 10%
May 7, 2003: Gamimune®
N, 10%
FDA's Center for Biologics Evaluation and Research
The United States Food and Drug Administration's Center
for Biologics Evaluation and Research (CBER) holds the authority to regulate
biological products and ensure their safety for the American public. Visit
CBER's website to
learn more about biological products, including IGIV, in the United States.
Additional Resources
| Location |
Description |
Baxter Healthcare Corporation:
www.baxter.com/
and www.immunedisease.com |
Baxter Healthcare Corporation is responsible for production of Gammagard S/D, Immune Globulin Intravenous, Iveegam and Iveegam EN, Immune Globulin Intravenous. This web site includes information about this product and immune diseases as well as links to other relevant web sites. |
CSL Behring.:
www.cslbehring.com
Customer Support Hotline:
(800) 683-1288
Reimbursement Services Hotline: (800) 676-4266
|
CSL Behring provides Carimune NF, Immune Globulin Intravenous and Gammar-P.I.V. Immune Globulin Intravenous in the United States of America. Information about CLS Behring products and technical support are available for patients and professionals on the website. |
Grifols USA:
www.grifolsusa.com
Telephone: (888) GRIFOLS |
Grifols USA is responsible for production of Flebogamma, Immune Globulin Intravenous. This website includes information about this product as well as other products manufactured by this company. |
InterMune Pharmaceuticals, Inc.:
www.intermune.com
Telephone hotline:
(800) 577-9112 |
InterMune Pharmaceuticals, Inc. is responsible for the production of ACTIMMUNE (interferon gamma-1b) Injection for the treatment of chronic granulomatous disease (CGD) this company has a reimbursement hotline and patient assistance program to help patients with insurance and reimbursement issues. |
Octapharma:
www.octapharma.com
|
Octapharma is responsible for production of Octagam Immune Globulin Intravenous. This website provides information about this product and other services offered by Octapharma. |
Plasma Protein Therapeutics Association (PPTA):
www.plasmatherapeutics.org
Telephone: (202) 789-3100 |
This organization is the primary advocate for the leading producers of plasma-based and related recombinant biological therapeutics. The web site provides specific information on the quality, safety, and efficacy of plasma products. |
Talecris Biotherapeutics:
www.talecris.com
Customer Service Hotline:
800-243-4153
Reimbursement Services Hotline: (800) 288-8374
|
Talecris Biotherapeutics is responsible for production of Gamunex Immune Globulin Intravenous and Gamimune N, 10%, Immune Globulin Intravenous. Information about these products and related links pertinent to primary immune deficiencies are included on this web site |
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