Warning Letters and Untitled Letters to Pharmaceutical Companies 2007

Warning Letters and Untitled Letters
to Pharmaceutical Companies
2000

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 month to view the letters in Adobe Acrobat format.

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. Go here for further information about Adobe Acrobat and download instructions.

Also see the "Cyber" Letters.

[2008] [2007] [2006] [2005] [2004] [2003] [2002] [2001] 2000 [1999] [1998] [1997]
Product Company Division Released Posted

December

Detrol Pharmacia and Upjohn DDMAC 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 DDMAC 12/27/2000 1/19/2001
Levothroid  Forest Laboratories, Inc. DDMAC 12/27/2000 1/19/2001
Nasonex Schering Corporation DDMAC 12/8/2000 12/15/2000
Site Inspection - Warning letter Tianjin Xin Xin Pharmaceutical Corp. DMPQ 12/14/2000 12/20/2000
Site Inspection - Warning Letter Societa Italiana Medicinali Scandicci DMPQ 12/6/2000 12/15/2000
Site Inspection - Warning Letter Xinjiang Pharmaceutical Factory DMPQ 12/18/2000 1/19/2001

November

Adderall Shire Richwood DDMAC 11/9/2000 11/9/2000
Argatroban injection  SmithKline Beecham Pharmaceuticals DDMAC 11/20/2000 12/6/2000
Celebrex (celecoxib) capsules G.D. Searle & Co. DDMAC 11/14/2000 12/6/2000
Daptomycin
Part 2, Part 3 
Cubist Pharmaceuticals DDMAC 11/22/2000 12/6/2000
Ditropan XL ALZA Corporation DDMAC 11/16/2000 12/20/2000
Protonix I.V. (pantoprazole sodium) Wyeth-Ayerst Research DDMAC 11/28/2000 12/6/2000
Sarafem (fluoxetine HCl) tablets Eli Lilly and Company DDMAC 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 DDMAC 11/15/2000 12/6/2000
Venofer (iron sucrose) injection American Regent Laboratories DDMAC 11/21/2000 12/6/2000
Zithromax (azithromycin) for oral suspension Pfizer DDMAC 11/9/2000 12/6/2000

October

Avandia (rosiglitazone maleate) tablets SmithKline Beecham DDMAC 10/20/2000 10/31/2000
Effexor XR (venlafaxine) extended release capsules Wyeth-Ayerst DDMAC 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 DDMAC 10/23/2000 10/31/2000
Periostat (docycycline hyclate) 20 mg capsules Collagenex Pharmaceuticals DDMAC 10/17/2000 10/19/2000
Renova (tretinoin emollient cream) Johnson and Johnson DDMAC 10/13/2000 10/19/2000

September

Alphagan (brimonidine tartrate ophthalmic solution) Allergan DDMAC 9/22/2000 9/25/2000
Altace (ramipril) capsules King Pharm. DDMAC 9/7/2000 9/25/2000
Bioresearch Monitoring - Warning Letter The Research Consortium DSI 9/27/2000 10/2/2000
Diprivan (propofol) injectable emulsion - Warning Letter AstraZeneca DDMAC 9/1/2000 9/7/2000
Evista (raloxifene HCl) tablets Eli Lilly and Company DDMAC 9/14/2000 9/25/2000
IND Inspection - Warning Letter Heyltex Corporation DSI 9/20/2000 10/2/2000
Rescula (unoprostone isopropyl ophthamic solution) Ciba Vision Corporation DDMAC 9/8/2000 9/8/2000
Site Inspection - Warning Letter Glaxo Wellcome DMPQ 9/19/2000 9/25/2000
Synsorb Pk Synsorb Biotech Inc. DDMAC 9/5/2000 9/8/2000

August

Ambien (zolpidem tartrate) G.D. Seale DDMAC 8/24/2000 1/24/2001
Claritin (loratadine) Schering Corporation DDMAC 8/18/2000 9/7/2000
Fareston (toremifene citrate) Shire Laboratories DDMAC 8/7/2000 8/9/2000

July

Ampligen Hemispherx Bipharma DDMAC 7/7/2000 7/17/2000
Azelex (Azelaic Acid) Allergan DDMAC 7/24/2000 8/2/2000
Innohep (tinzaparin sodium) injection DuPont Pharmaceuticals DDMAC 7/20/2000 8/2/2000
Nolvadex (tamoxifen citrate) AstraZeneca Pharam. DDMAC 7/20/2000 8/2/2000
Nutropin Depot (somatropin rDNA origin for injectable suspension) Genetech DDMAC 7/28/2000 8/2/2000
Prilosec (omeprazole) delayed-release AstraZeneca L.P. DDMAC 7/18/2000 7/24/2000
Sustiva (efavirenz) capsules DuPont Pharmaceuticals DDMAC 7/18/2000 8/17/2000
Thryox (levothyroxine sodium) tablets Jerome Stevens Pharm. DDMAC 7/3/2000 7/6/2000

June

Allegra (fexofendadine HCl) capsules Aventis Pharmaceuticals DDMAC 6/14/2000 6/29/2000
Alrex (loteprednol etabonate) ophthalmic suspension Bausch & Lomb DDMAC 6/27/2000 7/24/2000
Atridox (doxycyline hyclate, 10%) Block Drug Company DDMAC 6/29/2000 7/17/2000
Ciloxan (ciprofloxacin HCl) Alcon Laboratories DDMAC 6/12/2000 6/20/2000
Ditropan XL (oxybutynin chloride) Alza Corporation DDMAC 6/1/2000 7/17/2000
Doxil (doxorubicin HCl) liposome injection Alza Corporation DDMAC 6/7/2000 6/29/2000
Eloxatin (oxaliplatin) Sanofi-Synthelabo DDMAC 6/22/2000 7/17/2000
Famvir (famciclovir) SmithKline Beecham DDMAC 6/9/2000 6/29/2000
Rocephin (ceftriaxone sodium) IV/IM Hoffman-La Roche DDMAC 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 DDMAC 6/28/2000 7/17/2000
Viramune (nevirapine) tablets and oral suspension Boehringer Ingelheim Pharmaceuticals DDMAC 6/27/2000 7/17/2000

May

Accolate (zafirkulast) tablets AstraZeneca L.P. DDMAC 5/26/2000 7/18/200
Claritin (loratadine) tablets Schering Corporation DDMAC 5/26/2000 7/14/2000
Clinical Study - Warning Letter Institute for Advanced Clinical Research DSI 5/24/2000 7/18/2000
Flovent (fluticasone propionate) inhalation aerosol Glaxo Wellcome DDMAC 5/9/2000 5/22/2000
IND Promotion Eli Lilly and Company DDMAC 5/4/2000 7/18/2000
Neoral (cyclosporine) capsules and oral solution Novartis DDMAC 5/8/2000 7/24/2000
OxyContin (oxycodone hydochloride) Pudue Pharma L.P. DDMAC 5/11/2000 5/22/2000

April

Alocril (nedocromil sodium ophthalmic solution) Allergan DDMAC 4/4/2000 4/19/2000
Bioresearch Monitoring - Warning Letter Dorfner Family Medicine DSI 4/7/2000 10/2/2000
Celebrex (celecoxib) capsules and Ambien (zolpidem tartrate) tablets G.D. Searle Parkway DDMAC 4/6/2000 4/19/2000
Lotronex (alosetron hydrochloride) tablets Part 1 and Part 2 Glaxo Wellcome DDMAC 4/28/2000 5/11/2000
Remeron (mirtzapine) tablets Organon DDMAC 4/6/2000 7/24/2000
Site inspection - Warning Letter Gemeindezentrum DMPQ 4/10/2000 4/19/2000
Tamiflu (oseltamivir phosphate)
sample advertisement
Hoffman-La Roche DDMAC 4/14/2000 4/21/2000
Tequin (gatifloxacin) tablets/injection Bristol-Myers Squibb DDMDC 4/10/2000 4/25/2000
Thalomid (thalidomide) capsules -  Warning Letter Celgene Corporation DDMAC 4/21/2000 4/21/2000
Uprima (apomorphine HCl) tablets TAP Pharmaceutical Products DDMAC 4/12/2000 5/22/2000

March

Anvirzel Ozelle Pharmaceuticals, Inc. DDMAC 3/7/2000 3/16/2000
Avapro, Glucophage, and Taxol -  Warning Letter Bristol-Myers Squibb DDMAC 3/16/2000 3/30/2000
Claritin (loratadine) tablets Schering Corporation DDMAC 3/14/2000 3/16/2000
Duragesic (fentanyl transdermal system) Janssen Pharmacuetica DDMAC 3/30/2000 4/19/2000
Flonase (fluticasone propionate) nasal spray (TV) Glaxo Wellcome Inc. DDMAC 3/10/2000 3/16/2000
Flonase (fluticasone propionate) nasal spray (Newspaper) Glaxo Wellcome Inc. DDMAC 3/10/2000 3/16/2000
Loprox (ciclopirox) cream and lotion MEDICIS Pharmaceutical Group DDMAC 3/7/2000 3/16/2000
Neoral (cyclosporine) Novartis DDMAC 3/7/2000 6/13/2000
Prevacid (lansoprazole) delayed release capsules TAP Holdings DDMAC 3/15/2000 3/27/2000
Relenza (zanamivir for inhalation)
Advertisement sample A (4/26/00)
Advertisement sample B (4/26/00)
Advertisement sample C (4/26/00)
Glaxo Wellcome Inc. DDMAC 3/13/2000 3/16/2000
Xopenex (levalbuterol HCl) inhalation solution Sepracor DDMAC 3/23/2000 3/27/2000

February

Corlopam (fenoldopam mesylate) injection Elan Pharmaceuticals DDMAC 2/15/2000 2/29/2000
Prilosec (omeprazole) delayed-release capsules AstraZeneca DDMAC 2/4/2000 2/29/2000
Site Inspection - Warning Letter Pharmacia & Upjohn DMPQ 2/3/2000 2/29/2000
Viagra (sildenafil citrate) tablets Pfizer DDMAC 2/2/2000 2/29/2000

January

Camitor (levocamitine) injection Sigma-Tau Pharm. DDMAC 1/24/2000 5/11/2000
Levoxyl (levothyroxine sodium) tablets - Warning Letter Jones Pharma Inc. DDMAC 1/21/2000 1/28/2000
Site Inspection Shanhai Shen Xing Pharmaceutical Factory DMPQ 1/20/2000 2/29/2000
Sonata (zaleplon) capsules Wyeth-Ayerst DDMAC 1/27/2000 7/24/2000
Synthroid (levothyroxine sodium) tablets Knoll Pharmaceutical DDMAC 1/28/2000 7/24/2000

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