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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

ProductCompanyReleasedPosted
Efudex (fluorouracil) topical solutions and creamICN Pharmaceuticals, Inc.12/18/20011/14/2002
Genotropin (somatroping [rDNA] origin for injectionPharmacia Corporation12/13/20011/14/2002
Nolvadex (tamoxifen citrate) tabletsAstraZeneca Pharmaceuticals12/10/20011/14/2002
PravacholBristol-Myers Squibb12/3/20013/18/2004

November

ProductCompanyReleasedPosted
Luxiq (betahmethasone valerate) foam, 0.12%Connectics Corporation11/15/200111/28/2001
Magnevist (Gadopentetate dimeglumine) injectionBerlex Laboratories11/20/200111/28/2001
Protopic (tacrolimus) ointment 0.03%, 0.1%Fujisawa Healthcare, Inc.11/14/200111/29/2001
Quadramet (Samarium Sm-153 lexidronam) injectionBerlex Laboratories11/9/200111/28/2001
Site Inspection-Warning LetterAmerican Histolabs11/29/20011/14/2002

October

ProductCompanyReleasedPosted
Actonel (risedronate sodium tablets)Proctor & Gamble Pharmaceuticals10/9/200111/29/2001
Clinical Study-Warning LetterUniv. of Illinois10/4/200110/26/2001
Comtan (entacapone) tabletsNovartis Pharmaceuticals Corp.10/3/200110/9/2001
Differin (adapalene gel)Galderma Laboratories10/1/200110/3/2001
Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus Caplets-Warning LetterOmni Nutraceuticals, Inc.10/12/200110/24/2001
Melagesic PM Caplets-Warning LetterB.F. Archer & Co.10/12/200110/24/2001
Site Inspection-Warning LetterCoulston Foundation10/11/200112/5/2001
Site Inspection-Warning LetterSt. Anthony Memorial Health Center10/12/200110/24/2001
Zomig (zolmitriptan) AstraZeneca LP10/200110/9/2001

September

ProductCompanyReleasedPosted
Vioxx (rofecoxib) tablets-Warning LetterMerck & Co., Inc.9/17/20019/21/2001

August

ProductCompanyReleasedPosted
Sponsor-Investigator -Warning LetterMartin Scharf, PhD8/30/200110/26/2001
Sponsor-Investigator-Warning LetterWilliam M. Patterson, MD8/31/200110/26/2001
Luxiq (betamethasone valerate)Connectics8/13/20019/14/2001
RenagelGelTex Pharmaceuticals, Inc.8/17/20019/14/2001
Tasmar (tolcapone) tabletsRoche Laboratories8/2/20018/10/2001
Transderm Scop (scopolamine)Novartis8/31/20019/14/2001

July

ProductCompanyReleasedPosted
Avandia (rosiglitazone maleate) tablets-Warning LetterGlazoSmithKline7/17/20017/30/2001
IND No:  ZD1839, ZD0473, ZD1694, ZD9238, & Arimidex (ansastrozole) tabletsAstraZeneca Pharmaceuticals7/9/20017/26/2001
Cancidas (caspofungin acetate)Merck and Co, Inc.7/19/20017/30/2001
Cerezyme (imiglucerase)Genzyme Corp7/13/20017/26/2001
IRB Inspection- Warning LetterCatawba Memorial Hospital
7/16/2001
4/15/2008
Clinical Investigator-Warning LetterLori A. Nesbitt, PharmD, MBA7/6/20017/30/2001
IRB Inspection-Warning LetterNorthern Westchester Hospital Center
7/6/2001
4/15/2008
Clinical Investigator-Warning LetterPeter Krumpe, M.D.7/31/20019/14/2001
Clinical Investigator-Warning LetterCandace S. Brown, PharmD, FNP7/25/20019/14/2001
DepoCyt (cytarabine liposome) injectionSkyePharma7/26/20018/6/2001
Ditropan XL (oxybutynin chloride)Alza Corporation7/12/20017/30/2001
LipitorPfizer, Inc.7/12/20017/30/2001
Nisaspan (niacin extended-release) tablets-Warning LetterKos Pharmaceuticals7/13/20017/30/2001
Clinical Investigator - Warning Letter
 
Duttala O. Reddy, MD7/13/20017/13/2001
Taxotere (docetaxel) for injectionAventis Pharmaceuticals7/26/20018/6/2001
UFT (uracil and tegafur) capsulesBristol-Myers Squibb7/20/20017/30/2001
Xcytrin (motexafin gadolinium)Pharmacyclics, Inc.7/3/20019/14/2001

June

ProductCompanyReleasedPosted
Avandia (rosiglitazone maleate) tabletsGlaxoSmithKline6/28/20017/31/2001
Avelox (moxifloxacin HCl)Bayer Corporation6/29/20017/26/2001
Doxil (doxorubicine HCl) liposome injectionAlza Corporation6/28/20017/26/2001
Ecteinasicidin-743PharmaMar6/25/20017/26/2001
Fludara (fludarabine phosphate) for injectionBerlex Laboratories6/28/20017/26/2001
Fosamax (alendronate sodium) tabletsMerck & Co.6/20/20017/31/2001
Lovenox (enoxaparin sodium) injectionAventis Pharmaceuticals6/25/20017/26/2001
Lumigan (bimatroprost ophthalmic solution)Allergran, Inc.6/8/20017/26/2001
Navelbine (vinrorelbine tartrate) injectionGlaxoSmithKline, Inc.6/28/20017/26/2001
Neurontin (gabapentin)Pfizer, Inc.6/29/20017/31/2001
Plavix (clopidogrel bisulfate)Sanofi-Synthelabo, Inc.6/8/20017/26/2001
Site Inspection-Warning LetterFIDIA s.p.a.6/28/20017/26/2001
Site Inspection-Warning LetterYung Shin Pharm, Inc.6/28/20017/26/2001
Sporanox (itraconazole) capsulesJanssen Research Foundation6/27/20017/31/2001
Temodar (temozolomide) capsulesSchering Corporation6/28/20017/31/2001
VardenafilBayer Corporation6/6/20017/26/2001

May

ProductCompanyReleasedPosted
Ceplene (histamine dihydrochloride)Maxim Pharmaceuticals5/31/20016/11/2001
Nipent (pentostatin) for injectionSupergen, Inc.5/10/20015/22/2001
Plavix (clopidogrel bisulfate) tabletsSanofi-Synthelabo Inc.5/9/20015/22/2001
Prandin (repaglinide) tabletsNovo Nordisk Pharmaceuticals5/1/20015/15/2001
ProAmatine (midodrine hydrochloride) tabletsShire Pharmaceutical Development, Inc.5/7/20015/22/2001
RubitecanSupergen, Inc.5/10/20015/22/2001

April

ProductCompanyReleasedPosted
Estrostep (norethindrone acetate and ethinyl estradiol) tabletsPfizer, Inc.4/16/20014/24/2001
Miacalcin (calcitonin-salmon) nasal spray, Exelon (rivastigmine tartrate) capsulesNovartis4/2/20015/15/2001
Nilandron (nilutamide) tabletsAventis Pharmaceuticals4/10/20015/15/2001
Site Inspection - Warning LetterGranules India, Ltd.4/19/20014/26/2001
Site Inspection - Warning LetterOmicron Quimica, S.A.4/11/20014/24/2001

March

ProductCompanyReleasedPosted
Amaryl (glimepiride) tabletsAventis Pharmaceuticals3/8/20013/13/2001
Brevibloc (esmolol hydrochloride) injectionBaxter Pharmaceuticals3/26/20013/28/2001
Ceftin (cefuroxime axetil) tabletsLifecyle Ventures3/16/20013/28/2001
Ifex (ifosfamide) injectionBristol-Myers Squibb3/13/20013/21/2001
Lumigan (bimatoprost ophthalmic solution)Allergan, Inc.3/26/20015/15/2001
Miralax (polyethylene glycol 3350 NF Powder)Braintree Laboratories3/29/20015/15/2001
Patanol (olopatadine hydrochloride) ophthalmic solutionAlcon Research3/6/20013/13/2001
Plenaxis (abarelix) for injectable suspensionPraceis Pharmaceuticals3/26/20013/28/2001
Pravachol (pravastatin sodium)Bristol-Myers Squibb3/29/20015/15/2001
Xenical (orlistat) capsulesHoffman-La Roche, Inc.3/30/20015/15/2001

February

ProductCompanyReleasedPosted
Celebrex (celecoxib) capsules-Warning LetterPharmacia Corporation2/1/20011/6/2001
Celebrex (celecoxib) capsulesPharmacia Corporation2/2/20012/6/2001
Femara (letrozole) tabletsNovartis Pharmaceuticals Corporation2/2/20012/5/2001
Minocycline hydrochloride microspheresOraPharma, Inc.2/13/20013/28/2001
Protopic (tacrolimus) ointmentFujisawa Healthcare2/16/20012/28/2001

January

ProductCompanyReleasedPosted
MivacronAbbott Laboratories1/18/20011/19/2001
MultiHance (gadobenate dimeglumine)Bracco Diagnostics1/9/20012/5/2001
Prilosec (omeprazole) delayed-release capsulesAstraZeneca1/3/20013/21/2001
Site Inspection-Warning LetterPharmacia Corporation1/11/20011/19/2001
Site Inspection-Warning LetterPharmacia Corporation1/11/20011/19/2001