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Warning Letters 1998

1998 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...]


January 1998
Product/Issue Company/Individual Division Released Posted
Avapro (irbesartan) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 1/7 4/3
Avapro (irbesartan) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 1/29 4/3
Lescol (fluvastatin sodium) Novartis Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 1/26 4/3
Permax (pergolide mesylate) Tablets Athena Neurosciences Division of Drug Marketing, Advertising, and Communications 1/13 4/3
Pravachol (pravastatin sodium) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 1/26 4/3
Rhinocort (budesonide) nasal inhaler Astra USA Division of Drug Marketing, Advertising, and Communications 1/23 4/3
Tasmar (tolcapone) Tablets Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 1/12 4/3
Zocor Merck Division of Drug Marketing, Advertising, and Communications 1/26 4/3

February 1998
Product/Issue Company/Individual Division Released Posted
Azmacort (triamcinolone acetonide) Inhalation Aerosol Rhone-Poulenc Rorer Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 2/26 4/3
Bioresearch Monitoring Program Inspection Central Florida Medical Research Center Division of Scientific Investigation 2/18 6/5
Bioresearch Monitoring Program Inspection University of Southern California School of Medicine Division of Scientific Investigation 2/20 6/5
4/6/1999
Corlopam (fenoldopam mesylate) Injection Neurex Division of Drug Marketing, Advertising, and Communications 2/26 4/3
Detrusitol (tolterodine tartrate) Tablets Pharmacia and Upjohn Division of Drug Marketing, Advertising, and Communications 2/9 4/3
Inspection (Warning Letter) Ferring AB Division of Manufacturing and Product Quality 2/24 6/5
MetroCream (metronidazole) topical cream and
MetroGel (metronidazole) Topical Gel
Galderma Laboratories Division of Drug Marketing, Advertising, and Communications 2/13 4/3
MUSE (alprostadil) urethral suppository Vivus Division of Drug Marketing, Advertising, and Communications 2/19 4/3
Zestril (lisinopril) Zeneca Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 2/11 4/3

March 1998
Product/Issue Company/Individual Division Released Posted
Accutane (isotretinoin) Capsules (Warning Letter) Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 3/5 3/18
Atrovent (ipratropium bromide) 0.06% Nasal Spray Boehringer Ingelheim Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 3/25 4/8
Avapro (irbesartan) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 3/25 4/8
Bontril (phendimetrazine tartrate, USP) Tablets Carnick Laboratories Division of Drug Marketing, Advertising, and Communications 3/30 4/16
Depo-Provera (sterile medroxyprogesterone acetate) Pharmacia and Upjohn Division of Drug Marketing, Advertising, and Communications 3/19 4/3
Duragesic (fentanyl) transdermal system Janssen Pharmaceutica Division of Drug Marketing, Advertising, and Communications 3/5 4/3
EchoGen (perflenapent) emulsion (Warning Letter) Sonus Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 3/26 4/3
Four Way Fast Acting Nasal Spray Bristol-Myers Squibb DLNDC 3/3 6/5
Glucophage (meformin HCl) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 3/9 4/3
Inspection (Warning Letter) GlaxoWellcome Division of Manufacturing and Product Quality 3/20 6/5
Inspection (Warning Letter) Pharmacia & Upjohn Division of Manufacturing and Product Quality 3/25 6/5
Marinol (dronabinol) Capsules Roxane Laboratories Division of Drug Marketing, Advertising, and Communications 3/3 4/3
MetroGel (metronidazole) Topical Gel Galderma Laboratories Division of Drug Marketing, Advertising, and Communications 3/20 4/3
Nicotrol Inhaler (nicotine) inhalation system McNeil Consumer Products Division of Drug Marketing, Advertising, and Communications 3/19 4/3
Patanol (olopatadine HCl) ophthalmic solution Alcon Laboratories Division of Drug Marketing, Advertising, and Communications 3/20 4/3
Paxil (paroxetine HCl) Tablets SmithKline Beecham Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 3/9 4/3
Relafen (nabumetone) Tablets (Warning Letter) SmithKline Beecham Pharm. Division of Drug Marketing, Advertising, and Communications 3/13 3/18
Selegiline Tablets Lederle Laboratories Division of Drug Marketing, Advertising, and Communications 3/18 4/3
Skin-Cap Cheminova International DLNDC 3/4 6/5
Timentin (ticarcillin disodium/clavulanate postassium) SmithKline Beecham Division of Drug Marketing, Advertising, and Communications 3/18 4/3
Various Unapproved Prescription Drugs Longevity Products DLND 3/3 6/5
Zyrtec (certirizine HCl) Tablets Pfizer Division of Drug Marketing, Advertising, and Communications 3/4 4/3

April 1998
Product/Issue Company/Individual Division Released Posted
Accolate (zafirkulast) Tablets Zeneca Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 4/1 4/9
Aerobid/Aerobid-M (flunisolide) Inhaler system Forest Laboratories Division of Drug Marketing, Advertising, and Communications 4/20 4/28
Allegra (fexofenadine HCl) Capsules 60 mg Hoechst Marion Roussel Division of Drug Marketing, Advertising, and Communications 4/8 4/16
Claritin (loratadine) Tablets Schering Division of Drug Marketing, Advertising, and Communications 4/27 5/7
Cosopt (dorzolamide HCl - timolol maleate ophthalmic solution) Merck Division of Drug Marketing, Advertising, and Communications 4/23 4/28
Detrol (tolterodine tatrate) Tablets Pharmacia and Upjohn Division of Drug Marketing, Advertising, and Communications 4/1 4/9
Estratab (esterified estrogens) Tablets Solvay Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 4/7 4/16
F.F. Thompson Hosptial Institutional Review Board (IRB) Inspection (Warning Letter) FF Thompson Healthcare Systems Division of Scientific Investigation 4/14 6/5
Flovent (fluticasone propionate) inhalation aerosol Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 4/8 4/16
Floxmax (Tamsulosin HCl) Capsules 0.4 mg Boehringer Ingelheim Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 4/1 5/29
Monodox (doxycycline monohydrate) 100mg Capsules Oclassen Pharm. Division of Drug Marketing, Advertising, and Communications 4/28 5/7
Monurol (fosfomycin tromethamine) sachet Forest Lab. Division of Drug Marketing, Advertising, and Communications 4/27 5/7
MUSE (alprostadil) urethral suppository Vivus Division of Drug Marketing, Advertising, and Communications 4/1 4/9
Nicotrol Inhaler (nicotine) inhalation system McNeil Consumer Products Division of Drug Marketing, Advertising, and Communications 4/6 4/16
Norvasc (amlodipine besylate) Tablets Pfizer Pharmaceuticals Group Division of Drug Marketing, Advertising, and Communications 4/24 4/28
Oxistat (Oxiconazole Nitrate Cream) GlaxoWellcome Division of Drug Marketing, Advertising, and Communications 5/19 5/29
Propecia (finasteride) Tablets Merck Division of Drug Marketing, Advertising, and Communication 4/1 4/9
Serevent Diskus (salmeterol xinofoate inhalation powder) Glaxo Division of Drug Marketing, Advertising, and Communications 4/24 2/22/1999
Spiros (Albuterol Sulfate) Inhalation Powder Dura Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 4/30 8/3
Zyban (bupropion HCl) sustained-release Tablets Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 4/20 4/28

May 1998
Product/Issue Company/Individual Division Released Posted
Accolate (zafirkulast) Tablets Zeneca Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 5/20 5/29
Acticin (Permethrin) Cream Alpharma U.S. Pharmaceutical Division Division of Drug Marketing, Advertising, and Communications 5/6 5/29
Actiq (Oral Transmucosal Fentanyl Citrate) Anesta Division of Drug Marketing, Advertising, and Communications 5/27 6/3
Aggrastat (Tirofiban HCl) Injection and Injection, Premixed Merck Division of Drug Marketing, Advertising, and Communications 5/11 5/29
Alprox-TD (Alprostadil) NexMed Division of Drug Marketing, Advertising, and Communications 5/26 6
Avapro (irbesartan) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 5/28 6/5
Detrol (tolterodine tatrate) Tablets Pharmacia and Upjohn Division of Drug Marketing, Advertising, and Communications 5/29 4/9
Dovonex (Calcipotriene) Ointment Westwood-Squibb Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 6/6 6/9
Emla Cream (Lidocaine and Prilocaine) Astra USA Division of Drug Marketing, Advertising, and Communications 5/22 6/5
Excedrin Extra Strength (Warning Letter) Bristol-Myers DLNDC 5/8 6/5
Flagyl ER (Metronidazole) Tablets (Warning Letter) G.D. Searle Division of Drug Marketing, Advertising, and Communications 5/26 8/3
Keri Anti-Bacterial Hand Lotion (Warning Letter) Bristol-Myers Squibb DLNDC 5/6 6/5
Naproxen Delayed Release Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 5/26 8/3
Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer Division of Drug Marketing, Advertising, and Communications 5/7 5/29
Pacerone (Amiodarone HCl) Tablets Upsher-Smith Division of Drug Marketing, Advertising, and Communications 5/28 6/5
Pravachol (pravastatin sodium) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 5/1 6/16
Premarin (Conjugated Estrogens) Tablets Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 5/20 6/5
Rilutek (Riluzole) Tablets Rhone-Poulenc Rorer Division of Drug Marketing, Advertising, and Communications 5/6 5/29
Taxol (Paclitaxel) Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 5/4 5/29
Xenical (Orlistat Tetrahydrolipstatin) Hoffmann-La Roce Division of Drug Marketing, Advertising, and Communications 5/14 5/29

June 1998
Product/Issue Company/Individual Division Released Posted
Aerobid/Aerobid-M (flunisolide) Inhaler system (Warning Letter) Forest Laboratories Division of Drug Marketing, Advertising, and Communications 6/26 6/29
Astelin (Azelastine HCl) Nasal Spray Carter-Wallace Division of Drug Marketing, Advertising, and Communications 6/4 6/9
Cozaar (Losartan Postassium) Tablets and Hyzaar (Losartan Postassium - Hydrochlorothiazide) Tablets Merck Division of Drug Marketing, Advertising, and Communications 6/4 6/9
Depacon (Valproate Sodium) Injection (Warning Letter) Abbott Laboratories Division of Drug Marketing, Advertising, and Communications 6/26 7/8
Follistim (Follitropin) for Injection Organon Division of Drug Marketing, Advertising, and Communications 6/26 7/8
Inspection (Warning Letter) Nycomed-Amersham Division of Manufacturing and Product Quality 6/19 3/1/1999
Integrillin (Eptifibatide) Injection COR Therapeutics, Inc. Division of Drug Marketing, Advertising, and Communications 6/25 6/29
Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 6/29 8/3
Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon Division of Drug Marketing, Advertising, and Communications 6/1 6/9
Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 6/8 6/29
Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer Division of Drug Marketing, Advertising, and Communications 6/25 6/29
Nasonex (mometasone furoate monohydrate) nasal spray Schering Corporation Division of Drug Marketing, Advertising, and Communications 6/24 2/22/1999
Prandin (repaglinide) Tablets Novo Nordisk Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 6/30 8/6
Promotional Materials, Web Site Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 6/4 6/9
Propulsid (Cisapride) Tablets Janssen Pharmaceutica Division of Drug Marketing, Advertising, and Communications 6/4 6/9
Rebetron Combination Therapy Containing Rebetol (Ribavirin) Schering Division of Drug Marketing, Advertising, and Communications 6/12 6/29
Select Promotional Materials from Merck (Warning Letter) Merck Division of Drug Marketing, Advertising, and Communications 6/16 6/24
Xeloda (Capecitabine) Tablets Hoffman-La Roche Division of Drug Marketing, Advertising, and Communications 6/8 6/29

July 1998
Product/Issue Company/Individual Division Released Posted
Acular PF (Ketorolac Tromethamine) Ophthalmic Solution Hoffman-LaRoche Division of Drug Marketing, Advertising, and Communications 7/23 7/27
Alesse (Levonorgestrel and Ethinyl Estradiol) Tablets Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 7/29 8/3
Azmacort (triamcinolone acetonide) Inhalation Aerosol Rhone-Poulenc Rorer Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 7/9 7/21
Climara (Estradiol) Transdermal System Berlex Laboratories Division of Drug Marketing, Advertising, and Communications 7/9 7/21
Daypro (Oxaporzin) Tablets Searle Division of Drug Marketing, Advertising, and Communications 7/30 8/6
Demuflen (Ethynodiol Diacetate and Ethinyl Estradiol) Tablets Searle Division of Drug Marketing, Advertising, and Communications 7/29 8/3
Desogen (Desogestrel and Ethinyl Estradiol) Tablets Organon Division of Drug Marketing, Advertising, and Communications 7/29 8/3
Investigational New Drug for Iron Therapy Schein Pharmaceutical Division of Drug Marketing, Advertising, and Communications 7/14 7/27
Inspection (Warning Letter) Holopack Verpackimgstechnik Division of Manufacturing and Product Quality 7/8 10/21
Loxitane (Loxapine) Watson Laboratories Division of Drug Marketing, Advertising, and Communications 7/22 7/27
Marketing of Various Unapproved Drugs (Warning Letter) Murray Shore Pharmacy DLNDC 7/28 8/27
Noritate (Metronidazole) Cream Dermik Laboratories Division of Drug Marketing, Advertising, and Communications 7/2 7/21
OctreoScan (Kit for the preparation of indium In-111 Pentetreotide) Mallinckrodt Medical Division of Drug Marketing, Advertising, and Communications 7/22 7/27
Propecia (finasteride) Tablets Merck Division of Drug Marketing, Advertising, and Communications 7/30 8/6
Renova (tretinoin emoilient cream) Johnson & Johnson Division of Drug Marketing, Advertising, and Communications 7/23 2/22/1999
Singulair (Montelukast Sodium) Merck Division of Drug Marketing, Advertising, and Communications 7/13 7/27
Vitrasert Sterile Intravitreal Implant with Cytovene Bausch and Lomb Surgical Division of Drug Marketing, Advertising, and Communications 7/2 7/21
Voltaren Ophthalmic Solution Ciba Vision Division of Drug Marketing, Advertising, and Communications 7/16 7/27

August 1998
Product/Issue Company/Individual Division Released Posted
Amlactin Upsher Smith Laboratories DLNDC 8/5 8/27
Copaxone Teva Marion Partners Division of Drug Marketing, Advertising, and Communications 8/27 9/1
Cyclosporine Oral Solution SangStat Division of Drug Marketing, Advertising, and Communications 8/11 8/25
Flovent (fluticasone propionate) inhalation aerosol Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 8/4 8/11
Nasacort AQ (Triameinolone Acetonide) Nasal Spray Rhone-Poulenc Rorer Division of Drug Marketing, Advertising, and Communications 8/19 8/25
Nasonex (Mometazone Furoate Monohydrate) Nasal Spray Schering Corporation Division of Drug Marketing, Advertising, and Communications 8/14 8/25
Renova (Tretinoin) Emollient Cream Johnson & Johnson Division of Drug Marketing, Advertising, and Communications 8/18 8/25
Site Inspection (Warning Letter) Poli Industria Chimica S.p.A. Division of Manufacturing and Product Quality 8/24 9/8
Trivora (Levonorgestrel and Ethinyl Estradiol) Tablets Watson Laboratories Division of Drug Marketing, Advertising, and Communications 8/6 8/11
Trusopt (Dorzolamide HCL) Ophthalmic Solution Merck Division of Drug Marketing, Advertising, and Communications 8/20 8/25
Vanceril Schering Corporation Division of Drug Marketing, Advertising, and Communications 8/24 10/22

September 1998
Product/Issue Company/Individual Division Released Posted
Aldara (imiquimod) Cream 3M Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 9/29 11/3
Allegra (Fexofenadine HCl) Hoechst Marion Roussel Division of Drug Marketing, Advertising, and Communications 9/23 9/28
Avapro (Irbesatan) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 9/23 9/28
Biaxin (Clarithromycin) Filmtab Abbott Laboratories Division of Drug Marketing, Advertising, and Communications 9/18 9/28
Orphan Medical Website Orphan Medical Division of Drug Marketing, Advertising, and Communications 9/17 10/22
Pletal (Cilostazol) Tablets Otsuka Affairs Department Division of Drug Marketing, Advertising, and Communications 9/17 10/22
Topiglan MacroChem Corporation Division of Drug Marketing, Advertising, and Communications 9/24 10/6

October 1998
Product/Issue Company/Individual Division Released Posted
Ampligen Hemispherx Biopharma Division of Drug Marketing, Advertising, and Communications 10/15 10/22
Arava (leflunomide) tablets Hoechst Marion Roussel Division of Drug Marketing, Advertising, and Communications 10/23 12/22
Benzamycin Topical (erythromycin and benzoyl peroxide gel) Dermik Laboratories Division of Drug Marketing, Advertising, and Communications 10/6 12/22
Climara (estradiol transdermal system) Berlex Laboratories Division of Drug Marketing, Advertising, and Communications 10/21 11/3
Meridia (sibutramine hydrochloride monohydrate) capsules Knoll Pharmaceutical Division of Drug Marketing, Advertising, and Communications 10/22 12/22
Pravachol (pravastatin sodium) Tablets Bristol-Myers Squibb Division of Drug Marketing, Advertising, and Communications 10/19 10/22
Quinacrine Pellets Center for Research on Population and Security DLNDC 10/14 2/17/1999
Renagel capsules (sevelamer HCl) GelTex Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 10/23 12/22
Trovan Pfizer Division of Drug Marketing, Advertising, and Communications 10/8 10/19

November 1998
Product/Issue Company/Individual Division Released Posted
Aggrastat (tirofiban hydrochloride) injection Merck Division of Drug Marketing, Advertising, and Communications 11/19 12/22
AlSpiros (albuterol sulfate inhalation powder) Dura Pharmaceuticals Inc. Division of Drug Marketing, Advertising, and Communications 11/06 12/02
Androderm (testosterone transdermal system) SmithKline Beecham Division of Drug Marketing, Advertising, and Communications 12/25 12/09
Atacand (candesartan cilexetil) Tablets Astra Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 11/23 12/09
Caverject (alprostadil for injection) Pharmacia & Upjohn Division of Drug Marketing, Advertising, and Communications 11/25 12/09
Ceclor CD (cefaclor extended release tablets) Eli Lilly and Company Division of Drug Marketing, Advertising, and Communications 11/19 12/02
Cosopt (dorzolamide hydrochloride - timolol maleate ophthalmic solution) Merck & Co., Inc. Division of Drug Marketing, Advertising, and Communications 11/03 12/02
Inspection Proviron Fine Chemicals Division of Manufacturing and Product Quality 11/18 11/25
Lipitor (atorvastatin calcium) tablets Parke-Davis Division of Drug Marketing, Advertising, and Communications 11/23 12/09
Plavix (clopidogrel bisulfate) tablets Sanofi Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 11/23 12/22
Pletal (cilostazol) tablets Otsuka America Pharmaceutical Division of Drug Marketing, Advertising, and Communications 11/9 12/22
Thalomid (thalidomide) capsules Celgene Corporation Division of Drug Marketing, Advertising, and Communications 11/9 12/22
TobraDex (tobramycin 0.3% and dexamethasone 0.1%) Sterile Ophthalmic Suspension and Ointment Alcon Laboratories, Inc. Division of Drug Marketing, Advertising, and Communications 11/19 12/02
Xalatan (latanoprost solution) sterile ophthalmic solution Pharmacia & Upjohn Division of Drug Marketing, Advertising, and Communications 11/23 12/09
Zeneca Letters:

Zestril (lisinopril) tablets
Sular (nisoldipine) tablets
Nolvadex (tamoxifen citrate) tablets
Zomig (zolmitriptan) tablets
Casodex (bicalutamide) tablets
Zeneca Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 11/24 12/02

December 1998
Product/Issue Company/Individual Division Released Posted
Alesse (levonorgestrel and ethinyl estradiol) tablets Wyeth-Ayerst Division of Drug Marketing, Advertising, and Communications 12/9 12/21
Celebra (celecoxib) capsules G.D. Searle & Co. Division of Drug Marketing, Advertising, and Communications 12/8 1/5/1999
Condylox Gel (podofilox gel) Watson Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 12/22 12/23
Cozaar (losartan potassium) tablets and Hyzaar (losartan potassium-hydrochlorothiazide Merck Division of Drug Marketing, Advertising, and Communications 12/22 1/5/1999
Cutivate (fluticasone propionate) cream Glaxo Wellcome Division of Drug Marketing, Advertising, and Communications 12/16 12/23
Dynacin (minocycline HCl) capsules Medicis Pharmaceuitcal Division of Drug Marketing, Advertising, and Communications 12/22 12/23
Evista (raloxifene hydrochloride) Eli Lilly and Co. Division of Drug Marketing, Advertising, and Communications 12/23 1/5/1999
Flovent (fluticasone dipropionate) inhalation aerosol Glaxo Division of Drug Marketing, Advertising, and Communications 12/9 12/21
Qvar (beclomethasone dipropionate) inhalation aerosol Hoechst Marion Roussel Division of Drug Marketing, Advertising, and Communications 12/28 1/5/1999
Hycamtin (topotecan HCl) SmithKline Beecham Division of Drug Marketing, Advertising, and Communications 12/21 1/5/1999
Levlite (levonorgestrel and ethinyl estradiol) tablets Berlex Laboratories Division of Drug Marketing, Advertising, and Communications 12/9 12/21
Menest (esterified estrogen) tablets, USP Monarch Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 12/01 12/09
Novartis Site Inspection Novartis AG Division of Manufacturing and Product Quality/DPCDS 12/18 1/6/1999
Clinical Investigator - Warning Letter Donald E. Johnson, MD Division of Scientific Investigation 12/17 7/14/1999
Plavix (Clopidogrel bisulfate) tablets Sanofi Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 12/18 12/23
Sustiva (efavirenz) capsules DuPont Pharmaceuticals Division of Drug Marketing, Advertising, and Communications 12/10 12/21
Trovan I.V. (alatrofloxacin mesylate injection)-Warning Letter Pfizer Office of Compliance 12/1998 1/28/1999
Vanceril 84 mcg Double Strength (beclomethasone dipropionate inhalation aerosol Schering Corporation Division of Drug Marketing, Advertising, and Communications 12/10 12/21
Vanceril 84 mcg Double Strength (beclomethasone dipropionate inhalation aerosol) Schering Corporation Division of Drug Marketing, Advertising, and Communications 12/21 1/5/99
Vicoprofen (Hydrocodone Bitratrate) Knoll Pharmaceutical Company Division of Drug Marketing, Advertising, and Communications 12/9 12/21
Zanaflex (tizanidine HCl) tablets Athena Neurosciences Division of Drug Marketing, Advertising, and Communications 12/02 12/09
Zyrtec (cetirizine HCl) tablets and syrup Pfizer Inc. Division of Drug Marketing, Advertising, and Communications 12/21 1/5/99

 

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
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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.