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