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Warning Letters and Untitled Letters
to Pharmaceutical Companies

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.

Also see the "Cyber" Letters.

[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
Clinical Study-Warning Letter Discovery Alliance, Inc. 7/6/2001 7/30/2001
Clinical Study-Warning Letter Northern Westchester Hospital Center
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


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

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Date created: January 11, 2006; updated April 15, 2008

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