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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Warning Letters Regarding Advertising and Promotional Labeling (Biologics)

Warning Letters may be viewed in a searchable database that is located at the Warning Letters link under Key Resources below.

2010

  • Aralast NP [Alpha1-Proteinase Inhibitor (Human)] - 8/3/10 - Baxter International Inc.

2009

  • Magellan® Autologous Platelet Separator System - 12/23/09 - Arteriocyte, Inc.
  • Tisseel (Fibrin Sealant) – 4/14/09 – Baxter International Inc.

2008

  • Panhematin (Hemin for Injection) – 8/25/2008 - Ovation Pharmaceuticals, Inc.

2006

  • Histatrol (Positive Skin Test Control - Histamine) – 9/6/2006 – ALK-Abello, Inc
  • Bacillus anthracis Recombinant Protective Antigen 102 (rPA102) (anthrax vaccine) with Alum – 3/24/2006 – VaxGen Inc.

2005

  • THROMBIN-JMI [Thrombin, Topical, U.S.P. (Bovine Origin)] – 11/1/2005 – GenTrac, Incorporated
  • OCTAGAM 5% [Immune Globulin Intravenous (Human)] – 8/31/2005 – Octapharma USA, Inc.
  • FluMist (Influenza Virus Vaccine Live, Intranasal) – 6/21/2005 – MedImmune Vaccines, Inc.
  • PANHEMATIN (Hemin for Injection) – 6/2/2005 – Ovation Pharmaceuticals, Inc.
  • Flebogamma 5% [Immune Globulin Intravenous (Human)] – 3/16/2005 – Instituto Grifols
  • Nabi-HB [Hepatitis B Immune Globulin (Human)] – 1/6/2005 – Nabi Biopharmaceuticals

2004

  • DigiFab [Digoxin Immune Fab (Ovine)] – 11/19/2004 – Protherics Inc.
  • Zemaira [Alpha1-Proteinase Inhibitor (Human)] – 10/12/2004 – Aventis Behring L.L.C.
  • Rhophylac [RH0(D) Immune Globulin Intravenous (Human)] – 9/14/2004 – ZLB Bioplasma Inc.
  • NovoSeven [Coagulation Factor VIIa (Recombinant)] – 8/9/2004 - Novo Nordisk Pharmaceuticals, Inc.
  • Engerix-B [Hepatitis B Vaccine (Recombinant)], Havrix [Hepatitis A Vaccine, Inactivated], and Twinrix [Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine] – 7/6/2004 – GlaxoSmithKline
  • Crosseal [Fibrin Sealant (Human)] – 5/27/2004 – OMRIX biopharmaceuticals, Ltd.
  • ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method (rAHF-PFM)] – 5/25/2004 – Baxter Healthcare Corporation
  • Polygam S/D [Immune Globulin Intravenous (Human)]  – 5/11/2004 – Baxter Healthcare Corporation

2003

  • BOTOX COSMETIC (Botulinum Toxin Type A) – 6/23/2003 – Allergan, Inc.

2001

  • BOTOX (Botulinum Toxin Type A) – 8/22/2001 – Allergan, Inc.
  • Avonex (Interferon beta-1a) – 3/29/2001 – Biogen, Inc.

1999

  • Leukine (sargramostim) – 8/23/1999 – Immunex Corporation
  • Abbokinase (Urokinase) – 3/19/1999 – Abbott Laboratories
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Key Resources

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Contact FDA

301-827-3028
301-827-3528 Fax
Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, HFM-602

Rockville, MD 20852-1448