• 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 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

IC351

 

 

 

Lilly ICOS LLC Division of Marketing, Advertising, and Communications 1/3/2002 1/14/2002

Provigil (modafinil) tablets

 

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

 

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.  If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly.  Inquiries to FDA should be sent to:

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.