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Warning Letters 2003

2003 Warning Letters and Untitled Letters to Pharmaceutical Companies     

These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters.  For District Office Warning Letters see the Main FDA FOI Warning Letters Page.  Some of the letters have been redacted or edited to remove confidential information. Click on links for each month to view the letters in Adobe Acrobat format.

December 2003

Product Company Division Released Posted
Allegra (fexofenadine HCl) Tablets Aventis Pharmaceuticals DDMAC 12/30/2003 1/14/2004
Migranal (Dihydroergotamine Mesylate) Nasal Spray & D.H.E. 45 Injection Xcel Pharmaceuticals DDMAC 12/19/2003 12/30/2003
Follistim (follitropin beta for injection) Organon DDMAC 12/12/2003 12/18/2003

November 2003

Product Company Division Released Posted
Camptosar (irinotecan hydrochloride injection) Pfizer DDMAC 11/17/2003 11/20/2003
Taxotere (Warning Letter) Aventis DDMAC 11/12/2003 12/11/2003

October 2003

Product Company Division Released Posted
Covera-HS (verapamil hydrochloride) Pfizer DDMAC 10/24/2003 11/3/2003
Ethyol (amifostine) for injection MedImmune DDMAC 10/28/2003 11/3/2003
Merrem I.V. (meropenem for injection) AstraZeneca Pharmaceuticals DDMAC 10/3/2003 10/6/2003

September 2003

Product Company Division Released Posted
Accutane/2bBrands (Warning Letter) David Anderson Compliance 9/9/2003 9/12/2003
Accutane/2bbrands.com/drugstore (Warning Letter) David Anderson Compliance 9/9/2003 9/12/2003
Accutane/Edrugnet.com, 1accutane.com, accutane-acne-treatments-medication.com (Warning Letter) Eric Kaiser Compliance 9/9/2003 9/12/2003
Accutane/Medicapharma.com (Warning Letter) S. Vincent Compliance 9/9/2003 9/12/2003
Accutane/Medicine-Mexico (Warning Letter) Medicine-Mexico Compliance 9/9/2003 9/12/2003
Accutane/Smartmeds.ca Smart Med Pharmasave Compliance 9/10/2003 9/12/2003
Accutane/Today's Business (Warning Letter) Today's Business Compliance 9/9/2003 9/12/2003
Gliadel Wafer (polifeprosan 20 with carmustine implant) Guildford Pharmaceuticals, Inc. DDMAC 9/29/2003 10/2/2003
Prescription Drug Shipments (Warning Letter) G. Anthony Howard/CanaRx Services Compliance 9/16/2003 9/17/2003
Prescription Drug Shipments (Warning Letter) Robert Howard/CanaRx Services Compliance 9/16/2003 9/17/2003
Prescription Drug Shipments (Warning Letter) Joseph Todd/CanaRx Services Compliance 9/16/2003 9/17/2003

August 2003

Product Company Division Released Posted
Lamisil Novartis DDMAC 8/22/2003 8/29/2003
Nutropin Genentech, Inc. DDMAC 8/25/2003 8/27/2003
Pravachol (pravastatin sodium) Tablets - Warning Letter Bristol-Myers Squibb Company DDMAC 8/7/2003 8/8/2003
Solage (mequinol 2% tretinoin 0.01%) topical solution Galderma DDMAC 8/19/2003 9/3/2003

July 2003

Product Company Division Released Posted
Cipro HC Otic Suspension and Ciloxan Alcon Research DDMAC 7/18/2003 7/24/2003
Viread (tenofovir disoproxil fumarate) tablets - Warning Letter Gilead Sciences, Inc. DDMAC 7/29/2003 8/7/2003
Yasmin (drospirenone/ethinyl estradiol) tablets Berlex Laboratories DDMAC 7/10/2003 7/15/2003

June 2003

Product Company Division Released Posted
Amnesteem (isotretinoin) capsules King and Spaulding DDMAC 6/18/2003 6/19/2003
Drug Importation - Warning Letter CanadianDiscountDrugs Compliance 6/30/2003 11/6/2003
Flonase (fluticasone propionate) nasal spray GlaxoSmithKline DDMAC 6/19/2003 6/20/2003
Inspection Report - Warning Letter Clonmel Healthcare DCRMS 6/13/2003 7/24/2003
Zaditor (ketotifen fumarate) ophthalmic solution Novartis DDMAC 6/18/2003 6/24/2003
Zelnorm (tegaserod maleate) Tablets Novartis Pharmaceuticals Corporation DDMAC 6/27/2003 7/1/2003

May 2003

Product Company Division Released Posted
Clinical Inspection -Warning Letter William Sokol, M.D. DSI 5/27/2003 6/26/2003
Xeloda (capecitabine) tablets -Warning Letter Hoffman-La Roche DDMAC 5/29/2003 6/4/2003

March 2003

Product Company Division Released Posted
Hexamethonium Bromide -Warning Letter Alkis Togias, MD DSI 3/31/2003 4/17/2003
Street Drug Alternatives -Warning Letter Mr. John Hoover Compliance 3/31/2003 7/1/2003
Street Drug Alternatives -Warning Letter Stardust Industries Compliance 3/31/2003 7/1/2003
Street Drug Alternatives -Warning Letter Cherokee Naturals, Inc. Compliance 3/31/2003 7/1/2003
Street Drug Alternatives -Warning Letter Mr. Shaun Roberts Compliance 3/31/2003 7/1/2003
Street Drug Alternatives Mood Enhancers -Warning Letter Mr. Jason Pacey Compliance 3/31/2003 7/1/2003
Street Drug Alternatives Red Dawn/Trip2Nite/Herbal Ecstacy -Warning Letter Mr. Brian Petruzzi Compliance 3/31/2003 7/1/2003
Street Drug Alternatives Fantasy/Space/Bliss Capsules -Warning Letter Mr. Mark Hurlbur Compliance 3/31/2003 7/1/2003
Street Drug Alternatives Ecstacy -Warning Letter Ecstacy Melrose Compliance 3/31/2003 7/1/2003

February 2003

Product Company Division Released Posted
Quixin (levofloxacin ophthalmic solution), 0.5% Santen, Inc. DDMAC 2/20/2003 3/3/2003

January 2003

Product Company Division Released Posted
Climara (estradiol transdermal system) Berlex  DDMAC 1/6/2003 1/31/2003
OxyContin (oxycodone HCl controlled-release) Tablets -Warning Letter Purdue Pharma L.P. DDMAC 1/17/2003 1/22/2003
Quixin (levofloxacin ophthalmic solution), 0.5% Santen, Inc. DDMAC 2/20/2003 3/3/2003
    
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