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 | Discovery Alliance, Inc. | 7/6/2001 | 7/30/2001 |
| Clinical Study-Warning Letter | Rochester General Hospital | 7/6/2001 | 7/30/2001 |
| 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 |
