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/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 Parkway	Division 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:

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Freedom of Information Staff (HFI-35)
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The letters are arranged in chronological order by month. Click on the product name to view the letters in Adobe Acrobat (PDF) format.