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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/Issue Company/Individual Division Released Posted
Detrol Pharmacia and Upjohn Division of Drug Marketing, Advertising, and Communications 12/7/2000 12/15/2000
Doctor's Lotion - Warning Letter JIIM, L.L.C. DLNDC 12/14/2000 12/20/2000
Histamine Dihydrochloride Injection Maxim Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 12/27/2000 1/19/2000
Levothroid Forest Laboratories, Inc. Division of Drug Marketing, Advertising, and Communications 12/27/2000 1/19/2001
Nasonex Schering Corporation Division of Drug Marketing, Advertising, and Communications 12/8/2000 12/15/2000
Site Inspection - Warning letter Tianjin Xin Xin Pharmaceutical Corp. Division of Manufacturing and Product Quality 12/14/2000 12/20/2000
Site Inspection - Warning Letter Societa Italiana Medicinali Scandicci Division of Manufacturing and Product Quality 12/6/2000 12/15/2000
Site Inspection - Warning Letter Xinjiang Pharmaceutical Factory Division of Manufacturing and Product Quality 12/18/2000 1/19/2001

November 2000
Product/Issue Company/Individual Division Released Posted
Adderall Shire Richwood Division of Drug Marketing, Advertising, and Communications 11/9/2000 11/9/2000
Argatroban injection SmithKline Beecham Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 11/20/2000 12/6/2000
Celebrex (celecoxib) capsules G.D. Searle & Co. Division of Drug Marketing, Advertising, and Communications 11/14/2000 12/6/2000
Daptomycin
Part 2, Part 3 
Cubist Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 11/22/2000 12/6/2000
Ditropan XL ALZA Corporation Division of Drug Marketing, Advertising, and Communications 11/16/2000 12/20/2000
Protonix I.V. (pantoprazole sodium) Wyeth-Ayerst Research Division of Drug Marketing, Advertising, and Communications 11/28/2000 12/6/2000
Sarafem (fluoxetine HCl) tablets Eli Lilly and Company Division of Drug Marketing, Advertising, and Communications 11/16/2000 12/6/2000
Site Inspection - Warning Letter Jiangsu Hengrui Medicine Co., Ltd. DMPQ 11/29/2000 12/6/2000
Site Inspection - Warning Letter SOL Pharmaceuticals Limited DMPQ 11/21/2000 12/6/2000
Vaniqa (eflornithrine hydrochloride) cream Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 11/15/2000 12/6/2000
Venofer (iron sucrose) injection American Regent Laboratories Division of Drug Marketing, Advertising, and Communications 11/21/2000 12/6/2000
Zithromax (azithromycin) for oral suspension Pfizer Division of Drug Marketing, Advertising, and Communications 11/9/2000 12/6/2000

October 2000
Product/Issue Company/Individual Division Released Posted
Avandia (rosiglitazone maleate) tablets SmithKline Beecham Division of Drug Marketing, Advertising, and Communications 10/20/2000 10/31/2000
Effexor XR (venlafaxine) extended release capsules Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 10/11/2000 10/17/2000
GEDA PLUS and SURETE - Warning Letter Optima Worldwide OC 10/6/2000 10/19/2000
Inspection- Warning Letter Spolana a.s. DMPQ 10/30/2000 11/3/2000
Norco (hydrocodone bitrartrate and acetaminophen) tablets Watson Laboratories Division of Drug Marketing, Advertising, and Communications 10/23/2000 10/31/2000
Periostat (docycycline hyclate) 20 mg capsules Collagenex Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 10/17/2000 10/19/2000
Renova (tretinoin emollient cream) Johnson and Johnson Division of Drug Marketing, Advertising, and Communications 10/13/2000 10/19/2000

September 2000
Product/Issue Company/Individual Division Released Posted
Alphagan (brimonidine tartrate ophthalmic solution) Allergan Division of Drug Marketing, Advertising, and Communications 9/22/2000 9/25/2000
Altace (ramipril) capsules King Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 9/7/2000 9/25/2000
Clinical Investigator - Warning Letter Jeffrey R. Levenson, MD
 
DSI 9/27/2000 10/2/2000
Diprivan (propofol) injectable emulsion - Warning Letter AstraZeneca Division of Drug Marketing, Advertising, and Communications 9/1/2000 9/7/2000
Evista (raloxifene HCl) tablets Eli Lilly and Company Division of Drug Marketing, Advertising, and Communications 9/14/2000 9/25/2000
Sponsor-Applicant-Monitor-CRO - Warning Letter Heyltex Corporation DSI 9/20/2000 10/2/2000
Rescula (unoprostone isopropyl ophthamic solution) Ciba Vision Corporation Division of Drug Marketing, Advertising, and Communications 9/8/2000 9/8/2000
Site Inspection - Warning Letter Glaxo Wellcome DMPQ 9/19/2000 9/25/2000
Synsorb Pk Synsorb Biotech Inc. Division of Drug Marketing, Advertising, and Communications 9/5/2000 9/8/2000

August 2000
Product/Issue Company/Individual Division Released Posted
Ambien (zolpidem tartrate) G.D. Seale Division of Drug Marketing, Advertising, and Communications 8/4/2000 1/24/2001
Claritin (loratadine) Schering Corporation Division of Drug Marketing, Advertising, and Communications 8/18/2000 9/7/2000
Fareston (toremifene citrate) Shire Laboratories Division of Drug Marketing, Advertising, and Communications 8/7/2000 8/9/2000

July 2000
Product/Issue Company/Individual Division Released Posted
Ampligen Hemispherx Bipharma Division of Drug Marketing, Advertising, and Communications 7/7/2000 7/17/2000
Azelex (Azelaic Acid) Allergan Division of Drug Marketing, Advertising, and Communications 7/24/2000 8/2/2000
Innohep (tinzaparin sodium) injection DuPont Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 7/20/2000 8/2/2000
Nolvadex (tamoxifen citrate) AstraZeneca Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 7/20/2000 8/2/2000
Nutropin Depot (somatropin rDNA origin for injectable suspension) Genetech Division of Drug Marketing, Advertising, and Communications 7/28/2000 8/2/2000
Prilosec (omeprazole) delayed-release AstraZeneca L.P. Division of Drug Marketing, Advertising, and Communications 7/18/2000 8/2/2000
Sustiva (efavirenz) capsules DuPont Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 7/18/2000 8/17/2000
Thryox (levothyroxine sodium) tablets Jerome Stevens Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 7/3/2000 7/6/2000

June 2000
Product/Issue Company/Individual Division Released Posted
Allegra (fexofendadine HCl) capsules Aventis Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 6/14/2000 6/29/2000
Alrex (loteprednol etabonate) ophthalmic suspension Bausch & Lomb Division of Drug Marketing, Advertising, and Communications 6/27/2000 7/24/2000
Atridox (doxycyline hyclate, 10%) Block Drug Company Division of Drug Marketing, Advertising, and Communications 6/29/2000 7/17/2000
Ciloxan (ciprofloxacin HCl) Alcon Laboratories Division of Drug Marketing, Advertising, and Communications 6/12/2000 6/20/2000
Ditropan XL (oxybutynin chloride) Alza Corporation Division of Drug Marketing, Advertising, and Communications 6/1/2000 7/17/2000
Doxil (doxorubicin HCl) liposome injection Alza Corporation Division of Drug Marketing, Advertising, and Communications 6/7/2000 6/29/2000
Eloxatin (oxaliplatin) Sanofi-Synthelabo Division of Drug Marketing, Advertising, and Communications 6/22/2000 7/17/2000
Famvir (famciclovir) SmithKline Beecham Division of Drug Marketing, Advertising, and Communications 6/9/2000 6/29/2000
Rocephin (ceftriaxone sodium) IV/IM Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 6/28/2000 7/24/2000
Site Inspection - Warning Letter Jiangsu Hengrui Medicine Co. DMPQ 6/19/2000 6/29/2000
Targretin (bexarotene) capsules Ligand Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 6/28/2000 7/17/2000
Viramune (nevirapine) tablets and oral suspension Boehringer Ingelheim Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 6/27/2000 7/17/2000

May 2000
Product/Issue Company/Individual Division Released Posted
Accolate (zafirkulast) tablets AstraZeneca L.P. Division of Drug Marketing, Advertising, and Communications 5/26/2000 7/18/2000
Claritin (loratadine) tablets Schering Corporation Division of Drug Marketing, Advertising, and Communications 5/26/2000 7/14/2000
Clinical Investigator - Warning Letter

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

DSI 5/24/2000 7/18/2000
Flovent (fluticasone propionate) inhalation aerosol Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 5/9/2000 5/22/2000
IND Promotion Eli Lilly and Company Division of Drug Marketing, Advertising, and Communications 5/4/2000 7/18/2000
Neoral (cyclosporine) capsules and oral solution Novartis Division of Drug Marketing, Advertising, and Communications 5/8/2000 7/24/2000
OxyContin (oxycodone hydochloride) Pudue Pharma L.P. Division of Drug Marketing, Advertising, and Communications 5/11/2000 5/22/2000

April 2000
Product/Issue Company/Individual Division Released Posted
Alocril (nedocromil sodium ophthalmic solution) Allergan Division of Drug Marketing, Advertising, and Communications 4/4/2000 4/19/2000
Clinical Investigator - Warning Letter Scott M. Dorfner, DO Division of Scientific Investigations 4/7/2000 10/2/2000
Celebrex (celecoxib) capsules and Ambien (zolpidem tartrate) tablets G.D. Searle ParkwayDivision of Drug Marketing, Advertising, and Communications 4/6/2000 4/19/2000
Lotronex (alosetron hydrochloride) tablets Part 1 and Part 2 Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 4/28/2000 5/11/2000
Remeron (mirtzapine) tablets Organon Division of Drug Marketing, Advertising, and Communications 4/6/2000 7/24/2000
Site inspection - Warning Letter Gemeindezentrum Division of Manufacturing & Product Quality 4/10/2000 4/19/2000
Tamiflu (oseltamivir phosphate)
sample advertisement
Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 4/14/2000 4/21/2000
Tequin (gatifloxacin) tablets/injection Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 4/10/2000 4/25/2000
Thalomid (thalidomide) capsules -  Warning Letter Celgene Corporation Division of Drug Marketing, Advertising, and Communications 4/21/2000 4/21/2000
Uprima (apomorphine HCl) tablets TAP Pharmaceutical Products Division of Drug Marketing, Advertising, and Communications 4/12/2000 5/22/2000

March 2000
Product/Issue Company/Individual Division Released Posted
Anvirzel Ozelle Pharmaceuticals, Inc. Division of Drug Marketing, Advertising, and Communications 3/7/2000 3/16/2000
Avapro, Glucophage, and Taxol -  Warning Letter Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 3/16/2000 3/30/2000
Clinical Investigator - Warning Letter Cal K. Cohn, M.D. DSI 3/29/2000 4/15/2000
Claritin (loratadine) tablets Schering Corporation Division of Drug Marketing, Advertising, and Communications 3/14/2000 3/16/2000
Duragesic (fentanyl transdermal system) Janssen Pharmacuetica Division of Drug Marketing, Advertising, and Communications 3/30/2000 4/19/2000
Flonase (fluticasone propionate) nasal spray (TV) Glaxo Wellcome Inc. Division of Drug Marketing, Advertising, and Communications 3/10/2000 3/16/2000
Flonase (fluticasone propionate) nasal spray (Newspaper) Glaxo Wellcome Inc. Division of Drug Marketing, Advertising, and Communications 3/10/2000 3/16/2000
Loprox (ciclopirox) cream and lotion MEDICIS Pharmaceutical Group Division of Drug Marketing, Advertising, and Communications 3/7/2000 3/16/2000
Neoral (cyclosporine) Novartis Division of Drug Marketing, Advertising, and Communications 3/7/2000 6/13/2000

Prevacid (lansoprazole) delayed release capsules

 

TAP Holdings Division of Drug Marketing, Advertising, and Communications 3/15/2000 3/27/2000

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 Communications 3/13/2000 3/16/2000

Xopenex (levalbuterol HCl) inhalation solution

 

 

Sepracor Division of Drug Marketing, Advertising, and Communications 3/23/2000 3/27/2000

February 2000
Product/Issue Company/Individual Division Released Posted

Corlopam (fenoldopam mesylate) injection

 

 

Elan Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 2/15/2000 2/29/2000

Prilosec (omeprazole) delayed-release capsules

 

 

AstraZeneca Division of Drug Marketing, Advertising, and Communications 2/4/2009 2/29/2000
Site Inspection - Warning Letter Pharmacia & Upjohn Division of Manufacturing & Product Quality 2/3/2000 2/29/2000
Viagra (sildenafil citrate) tablets Pfizer Division of Drug Marketing, Advertising, and Communications 2/2/2000 2/29/2000

January 2000
Product/Issue Company/Individual Division Released Posted

Camitor (levocamitine) injection

 

 

 

Sigma-Tau Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 1/24/2000 5/11/2000

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 Factory Division of Manufacturing & Product Quality 1/20/2000 2/29/2000
Sonata (zaleplon) capsules Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 1/27/2000 7/24/2000
Synthroid (levothyroxine sodium) tablets Knoll Pharmaceutical Division of Drug Marketing, Advertising, and Communications 1/28/2000 7/24/2000

 

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.