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Vaccines, Blood & Biologics

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

Key Resources

Contact FDA

Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1093 New Hampshire Avenue

WO Building 71

Silver Spring, MD 20993

Page Last Updated: 01/29/2015
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