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 2001 |
Product |
Company |
Released |
Posted |
Efudex (fluorouracil)
topical solutions and cream |
ICN Pharmaceuticals, Inc. |
12/18/2001 |
1/14/2002 |
Genotropin (somatroping
[rDNA] origin for injection |
Pharmacia Corporation |
12/13/2001 |
1/14/2002 |
Nolvadex (tamoxifen citrate)
tablets |
AstraZeneca Pharmaceuticals |
12/10/2001 |
1/14/2002 |
Pravachol |
Bristol-Myers Squibb |
12/3/2001 |
3/18/2004 |
November 2001 |
Product |
Company |
Released |
Posted |
Luxiq (betahmethasone
valerate) foam, 0.12% |
Connectics Corporation |
11/15/2001 |
11/28/2001 |
Magnevist
(Gadopentetate dimeglumine) injection |
Berlex Laboratories |
11/20/2001 |
11/28/2001 |
Protopic (tacrolimus)
ointment 0.03%, 0.1% |
Fujisawa Healthcare, Inc. |
11/14/2001 |
11/29/2001 |
Quadramet (Samarium
Sm-153 lexidronam) injection |
Berlex Laboratories |
11/9/2001 |
11/28/2001 |
Site Inspection-Warning
Letter |
American Histolabs |
11/29/2001 |
1/14/2002 |
October 2001 |
Product |
Company |
Released |
Posted |
Actonel (risedronate
sodium tablets) |
Procter & Gamble Pharmaceuticals |
10/9/2001 |
11/29/2001 |
Clinical Study-Warning
Letter |
Univ. of Illinois |
10/4/2001 |
10/26/2001 |
Comtan (entacapone)
tablets |
Novartis Pharmaceuticals Corp. |
10/3/2001 |
10/9/2001 |
Differin (adapalene
gel) |
Galderma Laboratories |
10/1/2001 |
10/3/2001 |
Inholtra Joint
Pain Caplets and Inholtra Joint Pain Plus Caplets-Warning Letter |
Omni Nutraceuticals, Inc. |
10/12/2001 |
10/24/2001 |
Melagesic PM
Caplets-Warning Letter |
B.F. Archer & Co. |
10/12/2001 |
10/24/2001 |
Site
Inspection-Warning Letter |
Coulston Foundation |
10/11/2001 |
12/5/2001 |
Site
Inspection-Warning Letter |
St. Anthony Memorial Health Center |
10/12/2001 |
10/24/2001 |
Zomig (zolmitriptan) |
AstraZeneca LP |
10/2001 |
10/9/2001 |
September 2001 |
Product |
Company |
Released |
Posted |
Vioxx (rofecoxib)
tablets-Warning Letter |
Merck & Co., Inc. |
9/17/2001 |
9/21/2001 |
August 2001 |
Product |
Company |
Released |
Posted |
Clinical Study-Warning
Letter |
Center for Research in Sleep Disorders |
8/30/2001 |
10/26/2001 |
Clinical Study-Warning
Letter |
Birmingham Research Group, Inc. |
8/31/2001 |
10/26/2001 |
Luxiq (betamethasone
valerate) |
Connectics |
8/13/2001 |
9/14/2001 |
Renagel |
GelTex Pharmaceuticals, Inc. |
8/17/2001 |
9/14/2001 |
Tasmar (tolcapone)
tablets |
Roche Laboratories |
8/2/2001 |
8/10/2001 |
Transderm Scop
(scopolamine) |
Novartis |
8/31/2001 |
9/14/2001 |
July 2001 |
Product |
Company |
Released |
Posted |
Avandia (rosiglitazone
maleate) tablets-Warning Letter |
GlazoSmithKline |
7/17/2001 |
7/30/2001 |
IND No: ZD1839,
ZD0473, ZD1694, ZD9238, & Arimidex (ansastrozole) tablets |
AstraZeneca Pharmaceuticals |
7/9/2001 |
7/26/2001 |
Cancidas (caspofungin
acetate) |
Merck and Co, Inc. |
7/19/2001 |
7/30/2001 |
Cerezyme (imiglucerase) |
Genzyme Corp |
7/13/2001 |
7/26/2001 |
Clinical Study- Warning Letter |
Catawba Memorial Hospital |
7/16/2001 |
4/15/2008 |
Clinical Study-Warning
Letter |
Discovery Alliance, Inc. |
7/6/2001 |
7/30/2001 |
Clinical Study-Warning
Letter |
Northern Westchester Hospital Center |
7/6/2001 |
4/15/2008 |
Clinical Study-Warning
Letter |
Peter Krumpe, M.D. |
7/31/2001 |
9/14/2001 |
Clinical Study-Warning
Letter |
University of Tennessee Medical Group |
7/25/2001 |
9/14/2001 |
DepoCyt (cytarabine
liposome) injection |
SkyePharma |
7/26/2001 |
8/6/2001 |
Ditropan XL (oxybutynin
chloride) |
Alza Corporation |
7/12/2001 |
7/30/2001 |
Lipitor |
Pfizer, Inc. |
7/12/2001 |
7/30/2001 |
Nisaspan (niacin
extended-release) tablets-Warning Letter |
Kos Pharmaceuticals |
7/13/2001 |
7/30/2001 |
Taxotere (docetaxel)
for injection |
Aventis Pharmaceuticals |
7/26/2001 |
8/6/2001 |
UFT (uracil and
tegafur) capsules |
Bristol-Myers Squibb |
7/20/2001 |
7/30/2001 |
Xcytrin (motexafin
gadolinium) |
Pharmacyclics, Inc. |
7/3/2001 |
9/14/2001 |
June 2001 |
Product |
Company |
Released |
Posted |
Avandia
(rosiglitazone maleate) tablets |
GlaxoSmithKline |
6/28/2001 |
7/31/2001 |
Avelox (moxifloxacin
HCl) |
Bayer Corporation |
6/29/2001 |
7/26/2001 |
Doxil (doxorubicine
HCl) liposome injection |
Alza Corporation |
6/28/2001 |
7/26/2001 |
Ecteinasicidin-743 |
PharmaMar |
6/25/2001 |
7/26/2001 |
Fludara (fludarabine
phosphate) for injection |
Berlex Laboratories |
6/28/2001 |
7/26/2001 |
Fosamax (alendronate
sodium) tablets |
Merck & Co. |
6/20/2001 |
7/31/2001 |
Lovenox (enoxaparin
sodium) injection |
Aventis Pharmaceuticals |
6/25/2001 |
7/26/2001 |
Lumigan (bimatroprost
ophthalmic solution) |
Allergran, Inc. |
6/8/2001 |
7/26/2001 |
Navelbine (vinrorelbine
tartrate) injection |
GlaxoSmithKline, Inc. |
6/28/2001 |
7/26/2001 |
Neurontin (gabapentin) |
Pfizer, Inc. |
6/29/2001 |
7/31/2001 |
Plavix (clopidogrel
bisulfate) |
Sanofi-Synthelabo, Inc. |
6/8/2001 |
7/26/2001 |
Site Inspection-Warning
Letter |
FIDIA s.p.a. |
6/28/2001 |
7/26/2001 |
Site Inspection-Warning
Letter |
Yung Shin Pharm, Inc. |
6/28/2001 |
7/26/2001 |
Sporanox
(itraconazole) capsules |
Janssen Research Foundation |
6/27/2001 |
7/31/2001 |
Temodar (temozolomide)
capsules |
Schering Corporation |
6/28/2001 |
7/31/2001 |
Vardenafil |
Bayer Corporation |
6/6/2001 |
7/26/2001 |
May 2001 |
Product |
Company |
Released |
Posted |
Ceplene (histamine
dihydrochloride) |
Maxim Pharmaceuticals |
5/31/2001 |
6/11/2001 |
Nipent (pentostatin) for
injection |
Supergen, Inc. |
5/10/2001 |
5/22/2001 |
Plavix (clopidogrel
bisulfate) tablets |
Sanofi-Synthelabo Inc. |
5/9/2001 |
5/22/2001 |
Prandin (repaglinide)
tablets |
Novo Nordisk Pharmaceuticals |
5/1/2001 |
5/15/2001 |
ProAmatine (midodrine
hydrochloride) tablets |
Shire Pharmaceutical Development, Inc. |
5/7/2001 |
5/22/2001 |
Rubitecan |
Supergen, Inc. |
5/10/2001 |
5/22/2001 |
April 2001 |
Product |
Company |
Released |
Posted |
Estrostep
(norethindrone acetate and ethinyl estradiol) tablets |
Pfizer, Inc. |
4/16/2001 |
4/24/2001 |
Miacalcin (calcitonin-salmon)
nasal spray, Exelon (rivastigmine tartrate) capsules |
Novartis |
4/2/2001 |
5/15/2001 |
Nilandron (nilutamide)
tablets |
Aventis Pharmaceuticals |
4/10/2001 |
5/15/2001 |
Site Inspection
- Warning Letter |
Granules India, Ltd. |
4/19/2001 |
4/26/2001 |
Site Inspection
- Warning Letter |
Omicron Quimica, S.A. |
4/11/2001 |
4/24/2001 |
March 2001 |
Product |
Company |
Released |
Posted |
Amaryl (glimepiride)
tablets |
Aventis Pharmaceuticals |
3/8/2001 |
3/13/2001 |
Brevibloc (esmolol
hydrochloride) injection |
Baxter Pharmaceuticals |
3/26/2001 |
3/28/2001 |
Ceftin (cefuroxime
axetil) tablets |
Lifecyle Ventures |
3/16/2001 |
3/28/2001 |
Ifex (ifosfamide)
injection |
Bristol-Myers Squibb |
3/13/2001 |
3/21/2001 |
Lumigan (bimatoprost
ophthalmic solution) |
Allergan, Inc. |
3/26/2001 |
5/15/2001 |
Miralax (polyethylene
glycol 3350 NF Powder) |
Braintree Laboratories |
3/29/2001 |
5/15/2001 |
Patanol (olopatadine
hydrochloride) ophthalmic solution |
Alcon Research |
3/6/2001 |
3/13/2001 |
Plenaxis (abarelix)
for injectable suspension |
Praceis Pharmaceuticals |
3/26/2001 |
3/28/2001 |
Pravachol (pravastatin
sodium) |
Bristol-Myers Squibb |
3/29/2001 |
5/15/2001 |
Xenical (orlistat)
capsules |
Hoffman-La Roche, Inc. |
3/30/2001 |
5/15/2001 |
February |
Product |
Company |
Released |
Posted |
Celebrex (celecoxib)
capsules-Warning Letter |
Pharmacia Corporation |
2/1/2001 |
1/6/2001 |
Celebrex (celecoxib)
capsules |
Pharmacia Corporation |
2/2/2001 |
2/6/2001 |
Femara (letrozole) tablets |
Novartis Pharmaceuticals Corporation |
2/2/2001 |
2/5/2001 |
Minocycline
hydrochloride microspheres |
OraPharma, Inc. |
2/13/2001 |
3/28/2001 |
Protopic (tacrolimus)
ointment |
Fujisawa Healthcare |
2/16/2001 |
2/28/2001 |
January 2001 |
Product |
Company |
Released |
Posted |
Mivacron |
Abbott Laboratories |
1/18/2001 |
1/19/2001 |
MultiHance (gadobenate dimeglumine) |
Bracco Diagnostics |
1/9/2001 |
2/5/2001 |
Prilosec (omeprazole)
delayed-release capsules |
AstraZeneca |
1/3/2001 |
3/21/2001 |
Site Inspection-Warning
Letter |
Pharmacia Corporation |
1/11/2001 |
1/19/2001 |
Site Inspection-Warning
Letter |
Pharmacia Corporation |
1/11/2001 |
1/19/2001 |