Drugs
Warning Letters 2002
2002 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 the links in each month to view the letters in Adobe Acrobat format. [more...]
December 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Retin-A Micro (tretinoin gel) microsphere | Johnson & Johnson | Division of Drug Marketing, Advertising, and Communications | 12/3/2002 | 12/10/2002 |
Taxotere (docetaxel) for injection | Aventis Pharmaceuticals | Division of Drug Marketing, Advertising, and Communications | 12/15/2002 | 1/31/2003 |
Transderm Scop (scopolamine) Transdermal Therapeutic System | Novartis | Division of Drug Marketing, Advertising, and Communications | 12/3/2002 | 11/14/2002 |
November 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Actos (pioglitazone hydrochloride) tablets | Takeda Pharmaceuticals North America, Inc. | Division of Drug Marketing, Advertising, and Communications | 11/7/2002 | 11/14/2002 |
Methotrexate, Leucovorin, and Amicar - Warning Letter | Xanodyne Pharmacal, Inc. | Division of Drug Marketing, Advertising, and Communications | 11/14/2002 | 11/26/2002 |
Plan B (levonorgestrel) tablets | Women's Capital Corporation | Division of Drug Marketing, Advertising, and Communications | 11/19/2002 | 11/26/2002 |
Reminyl (galantamine HBr) | Janssen Research Foundation. | Division of Drug Marketing, Advertising, and Communications | 11/20/2002 | 11/26/2002 |
Site Inspection (Warning Letter) | Mayne Pharma Pty., Ltd. | DMPQ | 11/21/2002 | 12/18/2002 |
Suprax (cefixime) Oral | Wyeth-Ayerst | Division of Drug Marketing, Advertising, and Communications | 11/5/2002 | 11/14/2002 |
October 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Guaifenesin: single product Warning Letters (45 total) | Multiple Companies | Office of Compliance | 10/11/2002 | 11/8/2002 |
Guaifenesin: mulitple products Warning Letters (26 total) | Multiple Companies | Office of Compliance | 10/11/2002 | 11/8/2002 |
Mobic (meloxicam) tablets | Boehringer Ingelheim Pharmaceuticals | Division of Drug Marketing, Advertising, and Communications | 10/24/2002 | 11/27/2002 |
Tracleer (bosentan) tablets | Actelion Pharmaceuticals US, Inc. | Division of Drug Marketing, Advertising, and Communications | 10/30/2002 | 11/14/2002 |
September 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Celexa | Forest Laboratories | Division of Drug Marketing, Advertising, and Communications | 9/13/2002 | 10/3/2002 |
Geodon (ziprasidone HCL) | Pfizer, Inc. | Division of Drug Marketing, Advertising, and Communications | 9/3/2002 | 9/19/2002 |
August 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Cedax (ceftibuten) | Biovail Pharmaceuticals | Division of Drug Marketing, Advertising, and Communications | 8/22/2002 | 9/19/2002 |
Lipitor (Atorvastatin calcium) tablets | Pfizer, Inc. | Division of Drug Marketing, Advertising, and Communications | 8/12/2002 | 9/4/2002 |
Prevacid (lansoprazole) delayed release capsules | TAP Pharmaceutical Products, Inc. | Division of Drug Marketing, Advertising, and Communications | 8/2/2002 | 9/4/2002 |
Zanaflex (Tizanidine HCL) tablets | Elan Pharmaceuticals | Division of Drug Marketing, Advertising, and Communications | 8/5/2002 | 9/4/2002 |
July 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Accutane (isotretinoin) capsules | Hoffman-LaRoche Inc. | Division of Drug Marketing, Advertising, and Communications | 7/25/2002 | 9/4/2002 |
Neurontin (gabapentin) | Pfizer | Division of Drug Marketing, Advertising, and Communications | 7/1/2002 | 7/18/2002 |
June 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Adipokinetix - Warning Letter | Better-Bodies | Office of Compliance | 6/12/2002 | 6/14/2002 |
Adrenalin - Warning Letter | Muscle Lane, Inc. | Office of Compliance | 6/12/2002 | 6/14/2002 |
Clinical Investigator - Warning Letter | Leonard J. Caputo, MD | DSI | 6/11/2002 | 6/18/2002 |
Clinical Investigator - Warning Letter | David R. Hassman, MD | DSI | 6/5/2002 | 6/18/2002 |
Hollywood Cuts - Warning Letter | Scientifically Advanced Nutrition | Office of Compliance | 6/12/2002 | 6/14/2002 |
Overdrive - Warning Letter | Diabetes Tea | Office of Compliance | 6/12/2002 | 6/14/2002 |
Phenylkinetics, Libido Magic - Warning Letter | 21st Century Sports Nutrionals, Inc. | Office of Compliance | 6/12/2002 | 6/14/2002 |
Lipodryl II - Warning Letter | ThermoLife International | Office of Compliance | 6/12/2002 | 6/14/2002 |
Ephedra or Ma Huang - Warning Letter | Herbtech | Office of Compliance | 6/12/2002 | 6/14/2002 |
May 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Imitrex (sumatriptan succinate) tablets | GlaxoSmithKline | Division of Drug Marketing, Advertising, and Communications | 5/13/2002 | 5/21/2002 |
Tamiflu (oseltamivir phosphate) capsules | Hoffman-La Roche | Division of Drug Marketing, Advertising, and Communications | 5/16/2002 | 6/7/2002 |
April 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Nicotine Lollipops - Warning Letter | Ashland Drug | Office of Compliance | 4/9/2002 | 5/21/2002 |
Nicotine Lollipops - Warning Letter | The Compounding Pharmacy | Office of Compliance | 4/9/2002 | 5/21/2002 |
Nicotine Lollipops - Warning Letter | Bird's Hill Pharmacy | Office of Compliance | 4/9/2002 | 5/21/2002 |
Zyrtec (cetirizine HCl) Tablets | Pfizer Inc. | Division of Drug Marketing, Advertising, and Communications | 4/30/2002 | 5/16/2002 |
March 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
Viread (tenofovir disoproxil fumarate) tablets
| Gilead Sciences, Inc. | Division of Drug Marketing, Advertising, and Communications | 3/14/2002 | 3/22/2002 |
January 2002
Product/Issue | Company/Individual | Division | Released | Posted |
---|---|---|---|---|
| Lilly ICOS LLC | Division of Marketing, Advertising, and Communications | 1/3/2002 | 1/14/2002 |
| Cephalon Inc. | Division of Drug Marketing, Advertising, and Communications | 1/3/2009 | 1/14/2002 |
Viread (tenofovir disoproxil fumarate) tablets
| Gilead Sciences, Inc. | Division of Drug Marketing, Advertising, and Communications | 3/14/2002 | 3/22/2002 |
Xalatan (latanoprost ophthalmic solution)
| Pharmacia & Upjohn | Division of Drug Marketing, Advertising, and Communications | 1/16/2002 | 2/20/2002 |
Xeloda (capecitabine) tablets | Hoffman-La Roche | Division of Drug Marketing, Advertising, and Communications | 1/9/2002 | 2/20/2002 |
Zanaflex (tizanidine HCl) tablets | Elan Pharmaceuticals | Division of Drug Marketing, Advertising, and Communications | 1/16/2002 | 2/20/2002 |
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857
Instructions for how to submit an FOI request can be found on the FDA FOI Page.
The letters are arranged in chronological order by month. Click on the product name to view the letters in Adobe Acrobat (PDF) format.