• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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

ProductCompanyDivisionReleasedPosted
Allegra (fexofenadine HCl) Tablets Aventis PharmaceuticalsDDMAC12/30/20031/14/2004
Migranal (Dihydroergotamine Mesylate) Nasal Spray & D.H.E. 45 Injection Xcel PharmaceuticalsDDMAC12/19/200312/30/2003
Follistim (follitropin beta for injection) OrganonDDMAC12/12/200312/18/2003

November 2003

ProductCompanyDivisionReleasedPosted
Camptosar (irinotecan hydrochloride injection) PfizerDDMAC11/17/200311/20/2003
Taxotere (Warning Letter) AventisDDMAC11/12/200312/11/2003

October 2003

ProductCompanyDivisionReleasedPosted
Covera-HS (verapamil hydrochloride)PfizerDDMAC10/24/200311/3/2003
Ethyol (amifostine) for injectionMedImmuneDDMAC10/28/200311/3/2003
Merrem I.V. (meropenem for injection)AstraZeneca PharmaceuticalsDDMAC10/3/200310/6/2003

September 2003

ProductCompanyDivisionReleasedPosted
Accutane/2bBrands (Warning Letter)David AndersonCompliance9/9/20039/12/2003
Accutane/2bbrands.com/drugstore (Warning Letter)David AndersonCompliance9/9/20039/12/2003
Accutane/Edrugnet.com, 1accutane.com, accutane-acne-treatments-medication.com (Warning Letter)Eric KaiserCompliance9/9/20039/12/2003
Accutane/Medicapharma.com (Warning Letter)S. VincentCompliance9/9/20039/12/2003
Accutane/Medicine-Mexico (Warning Letter)Medicine-MexicoCompliance9/9/20039/12/2003
Accutane/Smartmeds.caSmart Med PharmasaveCompliance9/10/20039/12/2003
Accutane/Today's Business (Warning Letter)Today's BusinessCompliance9/9/20039/12/2003
Gliadel Wafer (polifeprosan 20 with carmustine implant)Guildford Pharmaceuticals, Inc.DDMAC9/29/200310/2/2003
Prescription Drug Shipments (Warning Letter) G. Anthony Howard/CanaRx ServicesCompliance9/16/20039/17/2003
Prescription Drug Shipments (Warning Letter) Robert Howard/CanaRx ServicesCompliance9/16/20039/17/2003
Prescription Drug Shipments (Warning Letter) Joseph Todd/CanaRx ServicesCompliance9/16/20039/17/2003

August 2003

ProductCompanyDivisionReleasedPosted
LamisilNovartisDDMAC8/22/20038/29/2003
NutropinGenentech, Inc.DDMAC8/25/20038/27/2003
Pravachol (pravastatin sodium) Tablets - Warning Letter Bristol-Myers Squibb CompanyDDMAC8/7/20038/8/2003
Solage (mequinol 2% tretinoin 0.01%) topical solutionGaldermaDDMAC8/19/20039/3/2003

July 2003

ProductCompanyDivisionReleasedPosted
Cipro HC Otic Suspension and CiloxanAlcon ResearchDDMAC7/18/20037/24/2003
Viread (tenofovir disoproxil fumarate) tablets - Warning LetterGilead Sciences, Inc.DDMAC7/29/20038/7/2003
Yasmin (drospirenone/ethinyl estradiol) tabletsBerlex LaboratoriesDDMAC7/10/20037/15/2003

June 2003

ProductCompanyDivisionReleasedPosted
Amnesteem (isotretinoin) capsulesKing and SpauldingDDMAC6/18/20036/19/2003
Drug Importation - Warning LetterCanadianDiscountDrugsCompliance6/30/200311/6/2003
Flonase (fluticasone propionate) nasal sprayGlaxoSmithKlineDDMAC6/19/20036/20/2003
Inspection Report - Warning LetterClonmel HealthcareDCRMS6/13/20037/24/2003
Zaditor (ketotifen fumarate) ophthalmic solutionNovartisDDMAC6/18/20036/24/2003
Zelnorm (tegaserod maleate) TabletsNovartis Pharmaceuticals CorporationDDMAC6/27/20037/1/2003

May 2003

ProductCompanyDivisionReleasedPosted
Clinical Investigator -Warning LetterWilliam Sokol, M.D.DSI5/27/20036/26/2003
Xeloda (capecitabine) tablets -Warning LetterHoffman-La RocheDDMAC5/29/20036/4/2003

March 2003

ProductCompanyDivisionReleasedPosted
Hexamethonium Bromide -Sponsor-Investigator Warning LetterAlkis Togias, MDDSI3/31/20034/17/2003
Street Drug Alternatives -Warning LetterMr. John HooverCompliance3/31/20037/1/2003
Street Drug Alternatives -Warning LetterStardust IndustriesCompliance3/31/20037/1/2003
Street Drug Alternatives -Warning LetterCherokee Naturals, Inc.Compliance3/31/20037/1/2003
Street Drug Alternatives -Warning LetterMr. Shaun RobertsCompliance3/31/20037/1/2003
Street Drug Alternatives Mood Enhancers -Warning LetterMr. Jason PaceyCompliance3/31/20037/1/2003
Street Drug Alternatives Red Dawn/Trip2Nite/Herbal Ecstacy -Warning LetterMr. Brian PetruzziCompliance3/31/20037/1/2003
Street Drug Alternatives Fantasy/Space/Bliss Capsules -Warning LetterMr. Mark HurlburCompliance3/31/20037/1/2003
Street Drug Alternatives Ecstacy -Warning LetterEcstacy MelroseCompliance3/31/20037/1/2003

February 2003

ProductCompanyDivisionReleasedPosted
Quixin (levofloxacin ophthalmic solution), 0.5%Santen, Inc.DDMAC2/20/20033/3/2003

January 2003

ProductCompanyDivisionReleasedPosted
Climara (estradiol transdermal system)Berlex DDMAC1/6/20031/31/2003
OxyContin (oxycodone HCl controlled-release) Tablets -Warning Letter Purdue Pharma L.P.DDMAC1/17/20031/22/2003
Quixin (levofloxacin ophthalmic solution), 0.5%Santen, Inc.DDMAC2/20/20033/3/2003