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 month 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 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Inspection (Warning Letter) |
IIT Research |
DSI |
12/5/1005 |
12/20/2005 |
Clinical Investigation Inspection (Warning Letter) |
Raymond E. Tidman, M.D. |
DSI |
12/19/2005 |
1/11/2006 |
Zevalin (ibritumomab tiuxetan)
|
Biogen Idec Inc. |
DDMAC |
12/15/2005 |
2/8/2006 |
November 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
"Barbec Basics Natural Progesterone Cream" (Warning Letter)
PDF or HTML |
One Life USA |
DNDLC |
11/9/1005 |
11/10/2005 |
"HMS Queen's Progesterone" and "HMS King's Progesterone" (Warning Letter) PDF or HTML |
HMS Crown |
DNDLC |
11/9/2005 |
11/10/2005 |
Vitrase (hyaluronidase injection) |
ISTA Pharmaceuticals, Inc |
DDMAC |
11/2/2005 |
11/3/2005 |
Z-LABS Progesterone Cream (Warning Letter) PDF or HTML |
Bio-Health |
DNDLC |
11/9/2005 |
11/10/2005 |
Zyflo Filmtab (zileuton tablets) (Warning Letter) |
Critical Therapeutics, Inc. |
DDMAC |
11/8/2005 |
11/9/2005 |
October 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Clinical Study (Warning Letter) |
Dr. Spencer Jones |
DSI |
10/27/2005 |
11/2/2005 |
September 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Calcitriol Injection (Warning Letter) |
Nephrx |
DDMAC |
9/29/2005 |
9/30/2005 |
Cymbalta (duloxetine) |
Eli Lilly |
DDMAC |
9/9/2005 |
11/9/2005 |
Lumigan (bimatoprost) ophthalmic solution (Warning Letter) |
Allergan, Inc. |
DDMAC |
9/6/2005 |
9/8/2005 |
Travatan (travoprost ophthalmic solution) |
Alcon Research, Ltd. |
DDMAC |
9/22/2005 |
9/23/2005 |
August 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Nipent (pentostatin) for Injection (Warning Letter) |
SuperGen, Inc. |
DDMAC |
8/18/2005 |
8/22/2005 |
Site Inspection (Warning Letter) |
Similasan AG |
DMPQ |
8/16/2005 |
9/7/2005 |
July 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Domperidone (Warning Letter) |
Cape Drugs |
DNDLC |
7/11/2005 |
8/10/2005 |
Fuzeon (enfuvirtide) for Injection |
Hoffman-La Roche, Inc. |
DDMAC |
7/15/2005 |
7/18/2005 |
Inspection (Warning Letter) |
Litron Laboratories, Ltd. |
DSI |
7/1/2005 |
7/12/2005 |
Quadramet (Samarium SM 153 Lexidronam) Injection (Warning Letter) |
Cytogen Corporation |
DDMAC |
7/18/2005 |
7/19/2005 |
Site Inspection (Warning Letter) |
ACS Dobfar |
DMPQ |
7/21/2005 |
7/28/2005 |
Survanta (beractant) intreacheal suspension |
Abbott Laboratories |
DDMAC |
7/15/2005 |
7/19/2005 |
Tracleer (bosentan) Tablets (Warning Letter) |
Actelion Pharmaceuticals US, Inc. |
DDMAC |
7/20/2005 |
7/26/2005 |
ZYVOX (linezolid) injection, tablets, and oral suspension (Warning Letter) |
Pfizer, Inc. |
DDMAC |
7/20/2005 |
7/26/2005 |
June 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Clinical Study (Warning Letter) |
Clark Bishop, M.D. |
DSI |
6/7/2005 |
6/22/2005 |
Lidoderm (Lidocaine Patch 5%) (Warning Letter) |
Endo Pharmaceuticals Inc. |
DDMAC |
6/28/2005 |
6/29/2005 |
Strattera (atomoxetine HCl) |
Eli Lilly and Company |
DDMAC |
6/14/2005 |
6/16/2005 |
VisionBlue (trypan blue ophthalmic solution) (Warning Letter) |
Dutch Ophthalmic USA |
DDMAC |
6/28/2005 |
6/29/2005 |
May 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Zoloft |
Pfizer Pharmaceuticals |
DDMAC |
5/6/2005 |
5/6/2005 |
Ferrlecit |
Watson Pharmaceuticals |
DDMAC |
5/5/2005 |
5/6/2005 |
April 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
CIPRO HC OTIC (Warning Letter) |
Alcon Laboratories, Inc. |
DDMAC |
4/27/2005 |
4/28/2005 |
Levitra (vardenafil HCl) Tablets |
Bayer Pharmaceuticals, Corp. |
DDMAC |
4/13/2005 |
4/15/2005 |
Remodulin (treprostinil sodium) Injection (Warning Letter) |
United Therapeutics Corporation |
DDMAC |
4/13/2005 |
4/14/2005 |
Zyrtec (cetirizine HCl) (Warning Letter) |
Pfizer, Inc. |
DDMAC |
4/13/2005 |
4/15/2005 |
March 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Aggrenox (aspirin/extended-release dipyridamole) Capsules |
Boehringer Ingelheim Pharmaceuticals, Inc. |
DDMAC |
3/22/2005 |
3/23/2005 |
Crestor (rosuvastatin calcium) |
AstraZeneca Pharmaceuticals LP |
DDMAC |
3/8/2005 |
3/14/2005 |
Tindamax (tinidazole tablets) (Warning Letter) |
Presutti Laboratories, Inc. |
DDMAC |
3/30/2005 |
4/14/2005 |
February 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
Enbrel (etanercept) (Warning Letter) |
Amgen |
DDMAC |
2/18/2005 |
2/18/2005 |
Remicade |
Centocor |
DDMAC |
2/11/2005 |
2/14/2005 |
Site Inspection (Warning Letter) |
Germiphene Corporation |
DMPQ |
2/15/2005 |
3/21/2005 |
January 2005 |
Product/Issue |
Company/Individual |
Division |
Released |
Posted |
BMIS Inspection (Warning Letter) |
Gene Logic |
DSI |
1/28/2005 |
2/11/2005 |
Celebrex & Bextra |
Pfizer Inc. |
DDMAC |
1/10/2005 |
1/12/2005 |
Coreg (carvedilol) Tablets (Warning Letter) |
GlaxoSmithKline |
DDMAC |
1/31/2005 |
2/3/2005 |