Drugs

Warning Letters 2000


2000 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 links in each month to view the letters in Adobe Acrobat format. [more...]


December 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
DetrolPharmacia and UpjohnDivision of Drug Marketing, Advertising, and Communications12/7/200012/15/2000
Doctor's Lotion - Warning LetterJIIM, L.L.C.DLNDC12/14/200012/20/2000
Histamine Dihydrochloride InjectionMaxim PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications12/27/20001/19/2000
LevothroidForest Laboratories, Inc.Division of Drug Marketing, Advertising, and Communications12/27/20001/19/2001
NasonexSchering CorporationDivision of Drug Marketing, Advertising, and Communications12/8/200012/15/2000
Site Inspection - Warning letterTianjin Xin Xin Pharmaceutical Corp.Division of Manufacturing and Product Quality12/14/200012/20/2000
Site Inspection - Warning LetterSocieta Italiana Medicinali ScandicciDivision of Manufacturing and Product Quality12/6/200012/15/2000
Site Inspection - Warning LetterXinjiang Pharmaceutical FactoryDivision of Manufacturing and Product Quality12/18/20001/19/2001

November 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
AdderallShire RichwoodDivision of Drug Marketing, Advertising, and Communications11/9/200011/9/2000
Argatroban injectionSmithKline Beecham PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications11/20/200012/6/2000
Celebrex (celecoxib) capsulesG.D. Searle & Co.Division of Drug Marketing, Advertising, and Communications11/14/200012/6/2000
Daptomycin
Part 2, Part 3 
Cubist PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications11/22/200012/6/2000
Ditropan XLALZA CorporationDivision of Drug Marketing, Advertising, and Communications11/16/200012/20/2000
Protonix I.V. (pantoprazole sodium)Wyeth-Ayerst ResearchDivision of Drug Marketing, Advertising, and Communications11/28/200012/6/2000
Sarafem (fluoxetine HCl) tabletsEli Lilly and CompanyDivision of Drug Marketing, Advertising, and Communications11/16/200012/6/2000
Site Inspection - Warning LetterJiangsu Hengrui Medicine Co., Ltd.DMPQ11/29/200012/6/2000
Site Inspection - Warning LetterSOL Pharmaceuticals LimitedDMPQ11/21/200012/6/2000
Vaniqa (eflornithrine hydrochloride) creamBristol-Myers SquibbDivision of Drug Marketing, Advertising, and Communications11/15/200012/6/2000
Venofer (iron sucrose) injectionAmerican Regent LaboratoriesDivision of Drug Marketing, Advertising, and Communications11/21/200012/6/2000
Zithromax (azithromycin) for oral suspensionPfizerDivision of Drug Marketing, Advertising, and Communications11/9/200012/6/2000

October 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Avandia (rosiglitazone maleate) tabletsSmithKline BeechamDivision of Drug Marketing, Advertising, and Communications10/20/200010/31/2000
Effexor XR (venlafaxine) extended release capsulesWyeth-AyerstDivision of Drug Marketing, Advertising, and Communications10/11/200010/17/2000
GEDA PLUS and SURETE - Warning LetterOptima WorldwideOC10/6/200010/19/2000
Inspection- Warning LetterSpolana a.s.DMPQ10/30/200011/3/2000
Norco (hydrocodone bitrartrate and acetaminophen) tabletsWatson LaboratoriesDivision of Drug Marketing, Advertising, and Communications10/23/200010/31/2000
Periostat (docycycline hyclate) 20 mg capsulesCollagenex PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications10/17/200010/19/2000
Renova (tretinoin emollient cream)Johnson and JohnsonDivision of Drug Marketing, Advertising, and Communications10/13/200010/19/2000

September 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Alphagan (brimonidine tartrate ophthalmic solution)AllerganDivision of Drug Marketing, Advertising, and Communications9/22/20009/25/2000
Altace (ramipril) capsulesKing PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications9/7/20009/25/2000
Clinical Investigator - Warning LetterJeffrey R. Levenson, MD
 
DSI9/27/200010/2/2000
Diprivan (propofol) injectable emulsion - Warning LetterAstraZenecaDivision of Drug Marketing, Advertising, and Communications9/1/20009/7/2000
Evista (raloxifene HCl) tabletsEli Lilly and CompanyDivision of Drug Marketing, Advertising, and Communications9/14/20009/25/2000
Sponsor-Applicant-Monitor-CRO - Warning LetterHeyltex CorporationDSI9/20/200010/2/2000
Rescula (unoprostone isopropyl ophthamic solution)Ciba Vision CorporationDivision of Drug Marketing, Advertising, and Communications9/8/20009/8/2000
Site Inspection - Warning LetterGlaxo WellcomeDMPQ9/19/20009/25/2000
Synsorb PkSynsorb Biotech Inc.Division of Drug Marketing, Advertising, and Communications9/5/20009/8/2000

August 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Ambien (zolpidem tartrate)G.D. SealeDivision of Drug Marketing, Advertising, and Communications8/4/20001/24/2001
Claritin (loratadine)Schering CorporationDivision of Drug Marketing, Advertising, and Communications8/18/20009/7/2000
Fareston (toremifene citrate)Shire LaboratoriesDivision of Drug Marketing, Advertising, and Communications8/7/20008/9/2000

July 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
AmpligenHemispherx BipharmaDivision of Drug Marketing, Advertising, and Communications7/7/20007/17/2000
Azelex (Azelaic Acid)AllerganDivision of Drug Marketing, Advertising, and Communications7/24/20008/2/2000
Innohep (tinzaparin sodium) injectionDuPont PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications7/20/20008/2/2000
Nolvadex (tamoxifen citrate)AstraZeneca PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications7/20/20008/2/2000
Nutropin Depot (somatropin rDNA origin for injectable suspension)GenetechDivision of Drug Marketing, Advertising, and Communications7/28/20008/2/2000
Prilosec (omeprazole) delayed-releaseAstraZeneca L.P.Division of Drug Marketing, Advertising, and Communications7/18/20008/2/2000
Sustiva (efavirenz) capsulesDuPont PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications7/18/20008/17/2000
Thryox (levothyroxine sodium) tabletsJerome Stevens PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications7/3/20007/6/2000

June 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Allegra (fexofendadine HCl) capsulesAventis PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications6/14/20006/29/2000
Alrex (loteprednol etabonate) ophthalmic suspensionBausch & LombDivision of Drug Marketing, Advertising, and Communications6/27/20007/24/2000
Atridox (doxycyline hyclate, 10%)Block Drug CompanyDivision of Drug Marketing, Advertising, and Communications6/29/20007/17/2000
Ciloxan (ciprofloxacin HCl)Alcon LaboratoriesDivision of Drug Marketing, Advertising, and Communications6/12/20006/20/2000
Ditropan XL (oxybutynin chloride)Alza CorporationDivision of Drug Marketing, Advertising, and Communications6/1/20007/17/2000
Doxil (doxorubicin HCl) liposome injectionAlza CorporationDivision of Drug Marketing, Advertising, and Communications6/7/20006/29/2000
Eloxatin (oxaliplatin)Sanofi-SynthelaboDivision of Drug Marketing, Advertising, and Communications6/22/20007/17/2000
Famvir (famciclovir)SmithKline BeechamDivision of Drug Marketing, Advertising, and Communications6/9/20006/29/2000
Rocephin (ceftriaxone sodium) IV/IMHoffman-La RocheDivision of Drug Marketing, Advertising, and Communications6/28/20007/24/2000
Site Inspection - Warning LetterJiangsu Hengrui Medicine Co.DMPQ6/19/20006/29/2000
Targretin (bexarotene) capsulesLigand PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications6/28/20007/17/2000
Viramune (nevirapine) tablets and oral suspensionBoehringer Ingelheim PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications6/27/20007/17/2000

May 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Accolate (zafirkulast) tabletsAstraZeneca L.P.Division of Drug Marketing, Advertising, and Communications5/26/20007/18/2000
Claritin (loratadine) tabletsSchering CorporationDivision of Drug Marketing, Advertising, and Communications5/26/20007/14/2000
Clinical Investigator - Warning Letter

Anne L. Macek, MD
Howard S. Cummins, PhD

DSI5/24/20007/18/2000
Flovent (fluticasone propionate) inhalation aerosolGlaxo WellcomeDivision of Drug Marketing, Advertising, and Communications5/9/20005/22/2000
IND PromotionEli Lilly and CompanyDivision of Drug Marketing, Advertising, and Communications5/4/20007/18/2000
Neoral (cyclosporine) capsules and oral solutionNovartisDivision of Drug Marketing, Advertising, and Communications5/8/20007/24/2000
OxyContin (oxycodone hydochloride)Pudue Pharma L.P.Division of Drug Marketing, Advertising, and Communications5/11/20005/22/2000

April 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
Alocril (nedocromil sodium ophthalmic solution)AllerganDivision of Drug Marketing, Advertising, and Communications4/4/20004/19/2000
Clinical Investigator - Warning LetterScott M. Dorfner, DODivision of Scientific Investigations4/7/200010/2/2000
Celebrex (celecoxib) capsules and Ambien (zolpidem tartrate) tabletsG.D. Searle ParkwayDivision of Drug Marketing, Advertising, and Communications4/6/20004/19/2000
Lotronex (alosetron hydrochloride) tablets Part 1 and Part 2Glaxo WellcomeDivision of Drug Marketing, Advertising, and Communications4/28/20005/11/2000
Remeron (mirtzapine) tabletsOrganonDivision of Drug Marketing, Advertising, and Communications4/6/20007/24/2000
Site inspection - Warning LetterGemeindezentrumDivision of Manufacturing & Product Quality4/10/20004/19/2000
Tamiflu (oseltamivir phosphate)
sample advertisement
Hoffman-La RocheDivision of Drug Marketing, Advertising, and Communications4/14/20004/21/2000
Tequin (gatifloxacin) tablets/injectionBristol-Myers SquibbDivision of Drug Marketing, Advertising, and Communications4/10/20004/25/2000
Thalomid (thalidomide) capsules -  Warning LetterCelgene CorporationDivision of Drug Marketing, Advertising, and Communications4/21/20004/21/2000
Uprima (apomorphine HCl) tabletsTAP Pharmaceutical ProductsDivision of Drug Marketing, Advertising, and Communications4/12/20005/22/2000

March 2000
Product/IssueCompany/IndividualDivisionReleasedPosted
AnvirzelOzelle Pharmaceuticals, Inc.Division of Drug Marketing, Advertising, and Communications3/7/20003/16/2000
Avapro, Glucophage, and Taxol -  Warning LetterBristol-Myers SquibbDivision of Drug Marketing, Advertising, and Communications3/16/20003/30/2000
Clinical Investigator - Warning LetterCal K. Cohn, M.D.DSI3/29/20004/15/2000
Claritin (loratadine) tabletsSchering CorporationDivision of Drug Marketing, Advertising, and Communications3/14/20003/16/2000
Duragesic (fentanyl transdermal system)Janssen PharmacueticaDivision of Drug Marketing, Advertising, and Communications3/30/20004/19/2000
Flonase (fluticasone propionate) nasal spray (TV)Glaxo Wellcome Inc.Division of Drug Marketing, Advertising, and Communications3/10/20003/16/2000
Flonase (fluticasone propionate) nasal spray (Newspaper)Glaxo Wellcome Inc.Division of Drug Marketing, Advertising, and Communications3/10/20003/16/2000
Loprox (ciclopirox) cream and lotionMEDICIS Pharmaceutical GroupDivision of Drug Marketing, Advertising, and Communications3/7/20003/16/2000
Neoral (cyclosporine)NovartisDivision of Drug Marketing, Advertising, and Communications3/7/20006/13/2000

Prevacid (lansoprazole) delayed release capsules

 

TAP HoldingsDivision of Drug Marketing, Advertising, and Communications3/15/20003/27/2000

Relenza (zanamivir for inhalation)
Advertisement sample A (4/26/2000)
Advertisement sample B (4/26/2000)
Advertisement sample C (4/26/2000)

 

 

Glaxo Wellcome Inc.Division of Drug Marketing, Advertising, and Communications3/13/20003/16/2000

Xopenex (levalbuterol HCl) inhalation solution

 

 

SepracorDivision of Drug Marketing, Advertising, and Communications3/23/20003/27/2000

February 2000
Product/IssueCompany/IndividualDivisionReleasedPosted

Corlopam (fenoldopam mesylate) injection

 

 

Elan PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications2/15/20002/29/2000

Prilosec (omeprazole) delayed-release capsules

 

 

AstraZenecaDivision of Drug Marketing, Advertising, and Communications2/4/20092/29/2000
Site Inspection - Warning LetterPharmacia & UpjohnDivision of Manufacturing & Product Quality2/3/20002/29/2000
Viagra (sildenafil citrate) tabletsPfizerDivision of Drug Marketing, Advertising, and Communications2/2/20002/29/2000

January 2000
Product/IssueCompany/IndividualDivisionReleasedPosted

Camitor (levocamitine) injection

 

 

 

Sigma-Tau PharmaceuticalsDivision of Drug Marketing, Advertising, and Communications1/24/20005/11/2000

Levoxyl (levothyroxine sodium) tablets - Warning Letterl

 

Jones Pharma Inc.   Division of Drug Marketing, Advertising, and Communications   1/21/2000    1/28/2000     

Site Inspection

 

 

Shanhai Shen Xing Pharmaceutical FactoryDivision of Manufacturing & Product Quality1/20/20002/29/2000
Sonata (zaleplon) capsulesWyeth-AyerstDivision of Drug Marketing, Advertising, and Communications1/27/20007/24/2000
Synthroid (levothyroxine sodium) tabletsKnoll PharmaceuticalDivision of Drug Marketing, Advertising, and Communications1/28/20007/24/2000

 

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.

Page Last Updated: 05/11/2016
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