Drugs
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 Investigator -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 -Sponsor-Investigator 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 |







