Drugs
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Warning Letters 2001
2001 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 links for each month to view the letters in Adobe Acrobat format.
December | |||
| 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 | |||
| 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 | |||
| Product | Company | Released | Posted |
| Actonel (risedronate sodium tablets) | Proctor & 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 | |||
| Product | Company | Released | Posted |
| Vioxx (rofecoxib) tablets-Warning Letter | Merck & Co., Inc. | 9/17/2001 | 9/21/2001 |
August | |||
| Product | Company | Released | Posted |
| Sponsor-Investigator -Warning Letter | Martin Scharf, PhD | 8/30/2001 | 10/26/2001 |
| Sponsor-Investigator-Warning Letter | William M. Patterson, MD | 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 | |||
| 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 |
| IRB Inspection- Warning Letter | Catawba Memorial Hospital | 7/16/2001 | 4/15/2008 |
| Clinical Investigator-Warning Letter | Lori A. Nesbitt, PharmD, MBA | 7/6/2001 | 7/30/2001 |
| IRB Inspection-Warning Letter | Northern Westchester Hospital Center | 7/6/2001 | 4/15/2008 |
| Clinical Investigator-Warning Letter | Peter Krumpe, M.D. | 7/31/2001 | 9/14/2001 |
| Clinical Investigator-Warning Letter | Candace S. Brown, PharmD, FNP | 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 |
| Clinical Investigator - Warning Letter | Duttala O. Reddy, MD | 7/13/2001 | 7/13/2001 |
| 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 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| 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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