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Drugs
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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 |
| Panretin | Johnson | 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 |
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.
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