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 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
BMIS Inspection |
MDS Pharma Services |
DSI |
12/21/2004 |
1/3/2005 |
Crestor (rosuvastatin calcium)
Tablets
|
AstraZeneca LP |
DDMAC |
12/21/2004 |
12/22/2004 |
Foradil Aerolizer
(formoterol fumarate inhalation powder)
|
Schering Corporation |
DDMAC |
12/09/2004 |
12/23/2004 |
Seasonale (levonorgestrel/ethinyl
estradiol) Tablets
|
Barr Research, Inc. |
DDMAC |
12/29/2004 |
12/30/2004 |
November 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
BMIS Inspection
(Warning Letter) |
Celsis Laboratory Group |
DSI |
11/29/2004 |
1/10/2005 |
Micardis (telmisartan)
|
Boehringer Ingelheim |
DDMAC |
11/24/2004 |
11/30/2004 |
Pamine (methscopolamine bromide) (Warning Letter)
|
Bradley Pharmaceuticals |
DDMAC |
11/9/2004 |
11/17/2004 |
Tramadol hydrochloride tablets
|
Mallinckrodt, Inc. |
DDMAC |
11/1/2004 |
11/15/2004 |
Viagra (sildenafil citrate) Tablets
|
Pfizer |
DDMAC |
11/10/2004 |
11/15/2004 |
October 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Kaletra (lopinavir/ritonavir) Capsules and
Oral Suspension
|
Abbott Laboratories |
DDMAC |
10/29/2004 |
11/2/2004 |
September 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Atrovent (ipratropium bromide) Inhalation
Aerosol and Combivent (ipratropium bromide and albuterol sulfate) Inhalation
Aerosol (Warning Leter)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
DDMAC |
9/23/2004 |
9/24/2004 |
Duragesic (fentanyl transdermal
system) (Warning Letter)
|
Janssen Pharmaceutica |
DDMAC |
9/3/2004 |
9/16/2004 |
Topamax (topiramate) Tablets and Topamax
(topiramate capsules) Sprinkles (Warning Letter)
|
Ortho-McNeil Pharmaceutical, Inc |
DDMAC |
9/15/2004 |
9/22/2004 |
Viadur (leuprolide acetate implant) (Warning
Letter)
|
Alza Corporation |
DDMAC |
9/21/2004 |
9/28/2004 |
Viramune (nevirapine) Tablets and Viramune (nevirapine)
Oral Suspension |
Boehringer Ingelheim Pharmaceuticals, Inc. |
DDMAC |
9/22/2004 |
9/22/2004 |
August 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Cubicin
(daptomycin for injection)
(Warning Letter) |
Cubist Pharmaceuticals |
DDMAC |
8/17/2004 |
8/24/2004 |
Site Inspection (Warning
Letter) |
Bigmar-Bioren SA |
Compliance |
8/3/2004 |
8/6/2004 |
June 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Domperidone (Warning
Letter) |
Axium Healthcare Pharmacy |
Compliance |
6/7/2004 |
6/7/2004 |
Domperidone (Warning
Letter) |
Drugs Are Us, Inc. DBA Hopewell Pharmacy |
Compliance |
6/7/2004 |
6/7/2004 |
Domperidone
(Warning Letter) |
Peoples Pharmacy, Inc. |
Compliance |
6/7/2004 |
6/7/2004 |
Domperidone (Warning Letter) |
Spectrum Chemicals & Laboratory Products |
Compliance |
6/7/2004 |
6/7/2004 |
Domperidone |
Line Avenue Pharmacy |
Compliance |
6/7/2004 |
6/7/2004 |
Norvir
(ritonavir capsules) (Warning Letter) |
Abbot Laboratories |
DDMAC |
6/10/2004 |
6/10/2004 |
Paxil CR
(paroxetine HCl) |
GlaxoSmithKline |
DDMAC |
6/2004 |
6/10/2004 |
May 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
MUSE (alprostadil) (Warning Letter) |
VIVUS, Inc. |
DDMAC |
5/25/2004 |
5/27/2004 |
Prograf. (tacrolimus) (Warning Letter) |
Fujisawa Healthcare, Inc. |
DDMAC |
5/7/2004 |
5/13/2004 |
April 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Diovan (Valsartan) (Warning Letter) |
Novartis |
DDMAC |
4/21/2004 |
4/29/2004 |
Facility Inspection |
MDS Pharma Services |
DSI |
4/26/2004 |
5/7/2004 |
Risperdal (risperidone) (Warning
Letter) |
Janssen |
DDMAC |
4/19/2004 |
4/29/2004 |
Zyrtec-D 12 Hour |
Pfizer |
DDMAC |
4/22/2004 |
4/29/2004 |
March 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Effexor, Effexor XR
|
Wyeth Pharmaceuticals |
DDMAC |
3/18/2004 |
2/26/2004 |
February 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
Bexxar (tositumomab and iodine I 131
tositumomab) (Warning Letter |
Corixa Corporation |
DDMAC |
3/16/2004 |
3/19/2004 |
Facility Inspection (Warning Letter) |
Shanghai Medical, Ltd. |
DMPQ |
2/10/2004 |
2/27/2004 |
Prescription Drug Importation
(Warning Letter) |
Discount Prescriptions from Canada, Inc. |
Compliance |
2/18/2004 |
2/19/2004 |
January 2004 |
Product/Issue |
Company |
Division |
Released |
Posted |
API Site Inspection (Warning Letter) |
Delta Synthetic Co. |
Compliance |
1/5/2004 |
5/19/2004 |
API Site Inspection (Warning Letter) |
Aliachem A.S. |
Compliance |
1/15/2004 |
5/19/2004 |
Prescription Drug Importation
(Warning Letter) |
- Expedite-RX
- SPC Global Technologies, Ltd.
- Employer Health Options, Inc.
|
Compliance |
1/22/2004 |
1/23/2004 |