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 month to view the letters in Adobe Acrobat format.
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. Go here for further information about Adobe Acrobat and download instructions.
[2008] [2007]
[2006]
[2005]
[2004]
[2003]
2002
[2001]
[2000]
[1999]
[1998]
[1997] |
December 2002 |
Product |
Company |
Division |
Released |
Posted |
Retin-A Micro (tretinoin gel) microsphere |
Johnson & Johnson |
DDMAC |
12/3/2002 |
12/10/2002 |
Taxotere (docetaxel) for injection |
Aventis Pharmaceuticals |
DDMAC |
12/15/2002 |
1/31/2003 |
Transderm Scop (scopolamine) Transdermal Therapeutic
System |
Novartis |
DDMAC |
12/3/2002 |
11/14/2002 |
November 2002 |
Product |
Company |
Division |
Released |
Posted |
Actos (pioglitazone hydrochloride) tablets |
Takeda Pharmaceuticals North America, Inc. |
DDMAC |
11/7/2002 |
11/14/2002 |
Methotrexate, Leucovorin, and Amicar -
Warning Letter |
Xanodyne Pharmacal, Inc. |
DDMAC |
11/14/2002 |
11/26/2002 |
Plan B (levonorgestrel) tablets |
Women's Capital Corporation |
DDMAC |
11/19/2002 |
11/26/2002 |
Reminyl (galantamine HBr) |
Janssen Research Foundation |
DDMAC |
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 |
DDMAC |
11/5/2002 |
11/14/2002 |
October 2002 |
Product |
Company |
Division |
Released |
Posted |
Guaifenesin:
single product Warning Letters (45 total) |
multiple companies |
Compliance |
10/11/2002 |
11/8/2002 |
Guaifenesin:
mulitple products Warning Letters (26 total) |
multiple companies |
Compliance |
10/11/2002 |
11/8/2002 |
Mobic (meloxicam) tablets |
Boehringer Ingelheim Pharmaceuticals |
DDMAC |
10/24/2002 |
11/27/2002 |
Tracleer (bosentan) tablets |
Actelion Pharmaceuticals US, Inc. |
DDMAC |
10/30/2002 |
11/14/2002 |
September 2002 |
Product |
Company |
Division |
Released |
Posted |
Celexa |
Forest Laboratories |
DDMAC |
9/13/2002 |
10/3/2002 |
Geodon (ziprasidone HCL) |
Pfizer, Inc. |
DDMAC |
9/3/2002 |
9/19/2002 |
August 2002 |
Product |
Company |
Division |
Released |
Posted |
Cedax (ceftibuten) |
Biovail Pharmaceuticals |
DDMAC |
8/22/2002 |
9/19/2002 |
Lipitor (Atorvastatin calcium) tablets |
Pfizer, Inc. |
DDMAC |
8/12/2002 |
9/4/2002 |
Prevacid (lansoprazole) delayed release
capsules |
TAP Pharmaceutical Products, Inc. |
DDMAC |
8/2/2002 |
9/4/2002 |
Zanaflex (Tizanidine HCL) tablets |
Elan Pharmaceuticals |
DDMAC |
8/5/2002 |
9/4/2002 |
July 2002 |
Product |
Company |
Division |
Released |
Posted |
Accutane (isotretinoin) capsules |
Hoffman-LaRoche Inc. |
DDMAC |
7/25/2002 |
9/4/2002 |
Neurontin (gabapentin) |
Pfizer |
DDMAC |
7/1/2002 |
7/18/2002 |
June 2002 |
Product |
Company |
Division |
Released |
Posted |
Adipokinetix - Warning Letter |
Better-Bodies |
Compliance |
6/12/2002 |
6/14/2002 |
Adrenalin - Warning Letter |
Muscle Lane, Inc. |
Compliance |
6/12/2002 |
6/14/2002 |
Clinical Study Inspection -
Warning Letter |
The Asthma and Allergy Institute |
DSI |
6/11/2002 |
6/18/2002 |
Clinical Study Inspection -
Warning Letter |
Comprehensive Clinical Research |
DSI |
6/5/2002 |
6/18/2002 |
Hollywood Cuts - Warning Letter |
Scientifically Advanced Nutrition |
Compliance |
6/12/2002 |
6/14/2002 |
Overdrive - Warning Letter |
Diabetes Tea |
Compliance |
6/12/2002 |
6/14/2002 |
Phenylkinetics, Libido Magic - Warning
Letter |
21st Century Sports Nutrionals, Inc. |
Compliance |
6/12/2002 |
6/14/2002 |
Lipodryl II - Warning Letter |
ThermoLife International |
Compliance |
6/12/2002 |
6/14/2002 |
Ephedra or Ma Huang - Warning
Letter |
Herbtech |
Compliance |
6/12/2002 |
6/14/2002 |
May 2002 |
Product |
Company |
Division |
Released |
Posted |
Imitrex (sumatriptan succinate) tablets |
GlaxoSmithKline |
DDMAC |
5/13/2002 |
5/21/2002 |
Tamiflu (oseltamivir phosphate) capsules |
Hoffman-La Roche |
DDMAC |
5/16/2002 |
6/7/2002 |
April 2002 |
Product |
Company |
Division |
Released |
Posted |
Nicotine Lollipops - Warning Letter |
Ashland Drug |
Compliance |
4/9/2002 |
5/21/2002 |
Nicotine Lollipops - Warning Letter |
The Compounding Pharmacy |
Compliance |
4/9/2002 |
5/21/2002 |
Nicotine Lollipops - Warning Letter |
Bird's Hill Pharmacy |
Compliance |
4/9/2002 |
5/21/2002 |
Zyrtec (cetirizine HCl) Tablets |
Pfizer Inc. |
DDMAC |
4/30/2002 |
5/16/2002 |
March 2002 |
Product |
Company |
Division |
Released |
Posted |
Viread (tenofovir disoproxil fumarate) tablets |
Gilead Sciences, Inc. |
DDMAC |
3/14/2002 |
3/22/2002 |
January 2002 |
Product |
Company |
Division |
Released |
Posted |
IC351 |
Lilly ICOS LLC |
DDMAC |
1/3/2002 |
1/14/2002 |
Provigil (modafinil) tablets |
Cephalon Inc. |
DDMAC |
1/3/2002 |
1/14/2002 |
Viread (tenofovir disoproxil fumarate) tablets |
Gilead Sciences, Inc. |
DDMAC |
3/14/2002 |
3/22/2002 |
Xalatan (latanoprost ophthalmic solution) |
Pharmacia & Upjohn |
DDMAC |
1/16/2002 |
2/20/2002 |
Xeloda (capecitabine) tablets |
Hoffman-La Roche |
DDMAC |
1/9/2002 |
2/20/2002 |
Zanaflex (tizanidine HCl) tablets |
Elan Pharmaceuticals |
DDMAC |
1/16/2002 |
2/20/2002 |