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 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 Inspection
-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
-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 |