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Warning Letters and Untitled Letters to Pharmaceutical Companies 2007

Warning Letters and Untitled Letters
to Pharmaceutical Companies
1997

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 month to view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.

In the News:   FDA Takes Action Against Firm Marketing Unapproved Drugs

[2008] [2007] [2006] [2005] [2004] [2003] [2002] [2001] [2000] [1999] [1998] 1997

January
Product Company Division Released
Caverject (alprostadil) for injection Pharmacia and Upjohn Company DDMAC 1/27/1997
Decapeptyl (Triptorelin Pamoate) Ferring Pharmaceuticals DDMAC 1/15/1997
Edex (Alprostadil) for Injection Schwarz Pharma DDMAC 1/24/1997
Floxin (ofloxacin injection and tablets) R.W. Johnson Pharmaceutical Research Institute DDMAC 1/8/1997
InFed (iron dextran injection) Schein Pharmaceutical, Inc. DDMAC 1/15/1997
Nipent Injection (pentostatin for injection) SuperGen, Inc. DDMAC 1/6/1997
Normodyne (labetalol HCL) tablets Schering Corporation DDMAC 1/23/1997
Novantrone (mitoxantrone) Immunex Corporation DDMAC 1/23/1997
Relafen (nabumetone) tablets SmithKline Beecham Pharmaceuticals DDMAC 1/23/1997
Site inspection Gist-Brocades BV DMPQ 1/27/1997
Site inspection Roquette Freres DMPQ 1/17/1997
Trasylol (aprotinin) injection Bayer Corporation, Pharmaceutical Division DDMAC 1/23/1997
Trophamine (6% and 10% amino acid injection) McGaw, Inc. DDMAC 1/29/1997
Valtrex (valacyclovir HCl) caplets Glaxo Wellcome Inc. DDMAC 1/29/1997
Vanceril 84 mcg Double Strength (beclomethasone dipropionate) inhalation aersol Schering Corporation DDMAC 1/24/1997
Zocor (simvastatin) Merck and Co. Inc. DDMAC 1/16/1997

February 1997
DaunoXome (daunorubicin citrate liposome injection) Nexstar Pharmaceuticals, Inc. DDMAC 2/21/1997
Elmiron (pentosan polysulfate sodium) Baker Norton Pharmaceuticals DDMAC 2/24/1997
Flonase (fluticasone propionate) Nasal Spray 0.05% w/w Glaxo Wellcome Inc. DDMAC 2/28/1997
Kytril (granisetron hydrochloride) tablets SmithKline Beecham DDMAC 2/27/1997
Maxair Autohaler (pirbuterol acetate inhalation aersol) 3M Pharmaceuticals DDMAC 2/27/1997
MaxAlert PDK Labs, Inc. DLNDC 2/24/1997
Mini Thin BDI Pharmaceuticals DLNDC 2/24/1997
Novantrone (mitoxantrone) Immunex Corporation DDMAC 2/14/1997
Rezulin (troglitazone) tablets Parke-Davis Pharmaceutical Research DDMAC 2/24/1997
Site inspection Dr. Mann Pharma DMPQ 2/18/1997
Site inspection Nippon Rikagakuyakuhin Co Ltd. DMPQ 2/19/1997
Site inspection Zeneca Pharmaceuticals DMPQ 2/19/1997
Trusopt (dorzolamide hydrochloride ophthalmic solution) Merck and Co, Inc. DDMAC 2/21/1997

March 1997
AmBisone (Liposomal Amphotericin B) Fujisawa USA DDMAC 3/19/1997
AmBisone (Liposomal Amphotericin B)      
Casodex (bicalutamide) Zeneca Pharmaceuticals DDMAC 3/27/1997
Claritin (Ioratadine) Syrup, 10mg/10ml Schering Corporation DDMAC 3/3/1997
Claritin (Ioratadine) tablets Schering Corporation DDMAC 3/10/1997
Ciloxan (ciprofloxacin HCl) 0.3% as base sterile ophthalmic solution Alcon Laboratories, Inc. DDMAC 3/4/1997
Claritin-D 24 Hour (10 mg loratadine & pseudoepherine 240 mg sulfate) extended-release tablets Schering Corporation DDMAC 3/26/1997
Climara (estradiol transdermal system) Forest Laboratories DDMAC 3/26/1997
Famvir (famciclovir) SmithKline Beecham Pharmaceuticals DDMAC 3/11/1997
Gemzar (gemcitabine HCl) Eli Lilly and Company DDMAC 3/19/1997
Hycamtin (topotecan HCl) SmithKline Beecham Pharmaceuticals DDMAC 3/20/1997
Monodox (doxycycline monohydrate) 100mg capsule Oclassen Pharmaceuticals, Inc. DDMAC 3/31/1997
Prinivil (lisinopril) tablets Merck & Co., Inc. DDMAC 3/14/1997
Sporanox (itraconazole capsules) Janssen Pharmaceutica DDMAC 3/27/1997
Ultane (sevoflurane) Abbott Laboratories DDMAC 3/17/1997

April 1997
Androgel (Testosterone) Gel Unimed Pharmaceuticals DDMAC 4/25/1997
Caverject (alprostadil) for injection Pharmacia and Upjohn Company DDMAC 4/28/1997
Cutivate (Fluticasone Propionate) Cream Glaxo Wellcome DDMAC  
Daypro (oxaprozin) tablets G.D. Searle & Co. DDMAC 4/10/1997
Fosamax (alendronate sodium tablets) Merck & Co., Inc. DDMAC 4/14/1997
Flovent (fluticasone propionate) inhalation Glaxo Wellcome Inc. DDMAC 4/28/1997
site inspection Guangdong Pharmaceutical Factory DMPQ 4/23/1997
site inspection (posted 11/4/1998) Novartis DMPQ 4/25/1997
Viracept (nefinavir mesylate) Agouron Pharmaceuticals, Inc. DDMAC 4/18/1997
Zyrtec (cetirizine HCl) tablets Pfizer Inc. DDMAC 4/4/1997
Zyrtec (cetirizine HCl) tablets Pfizer Inc. DDMAC 4/28/1997

May 1997
Product Company Division Released Posted
Crinone (progesterone) gel Wyeth-Ayerst Laboratories DDMAC 5/19/1997 6/3/1997
Hytrin (terazosin HCl) capsules Abbott Laboratories DDMAC 5/6/1997 5/16/1997
Site Inspection Irotec Laboratories, Ltd. DMPQ 5/16/1997 5/23/1997
Site Inspection Nippon Kayaku Co., Ltd DMPQ 5/23/1997 6/13/1997
Site Inspection Huls AkG Werk Witten Plant DMPQ 5/9/1997 5/16/1997
Lupron Depot (leuprolide acetate) TAP Holdings, Inc. DDMAC 5/29/1997 6/6/1997
Ocuflox (ofloxacin) ophthalmic solution 0.3% Allergan, Inc. DDMAC 5/30/1997 6/13/1997
Proventil-HFA (Albuterol Sulfate Inhalation Schering Corporation DDMAC 5/7/1997 5/16/1997
Uni-Dur (theophylline) extended release tablets Schering Corporation DDMAC 5/13/1997 6/3/1997

June 1997
Benefin Lane Labs-USA DDMAC 6/13/1997 6/3/1998
Efedrin (Maximum Strength) The Hammer Corporation DDMAC 6/10/1997 6/16/1997
Effexor (vanlafaxine HCl) Tablets Wyeth-Ayerst Laboratories DDMAC 6/25/1997 7/21/1997
Hytrin (terazosin) Abbott Laboratories DDMAC 6/10/1997 6/18/1997
ISIS 2302 ISIS Pharmaceuticals DDMAC 6/23/1997 6/23/1998
Lescol (fluvastatin sodium) Novartis Pharmaceuticals DDMAC 6/20/1997 7/21/1997
Levoxyl (Levothyroxine Sodium) Tablets Jones Medical Industries DDMAC 6/9/1997 6/3/1998
Miacalcin Nasal Spray (calcitonin salmon) Novartis DDMAC 6/25/1997 7/21/1997
Ocuflox (ofloxacin) ophthalmic solution 0.3% Allergan, Inc. DDMAC 6/23/1997 7/21/1997
Onconase AlfaCell DDMAC 6/2/1997 6/3/1998
Photofrin (porfimer sodium) QLT PhotoTherapeutics DDMAC 6/4/1997 6/13/1997
Unapproved Prescription Drugs Baxamed DLNDC 6/25/1997 7/21/1997
Miraluma (kit for the preparation of Technetium Tc-99m Sestamibil) DuPont Merck Radiopharmaceuticals DDMAC 6/27/1997 7/21/1997
Site Inspection Novopharm Ltd. DMPQi 6/27/1997 7/21/1997
Xenical (Orlistat) Capsules Hoffman-La Roche DDMAC 6/6/1997 6/3/1998
Zyflo (zileuton) tablets Abbott Laboratories DDMAC 6/27/1997 7/21/1997
Zyrtec (Cetirzine HCl) Tablets Pfizer DDMAC 6/1/1997 6/3/1998

July 1997
Celecoxib G.D. Searle DDMAC 7/16/1997 6/3/1998
Claritin (Loratadine) Tablets Schering Corporation DDMAC 7/9/1997 6/3/1998
Climara (Estradiol) Transdermal System Berlex DDMAC 7/22/1997 6/3/1998
Fosamax (alendronate) Sodium Tablets Merck & Co., Inc. DDMAC 7/2/1997 7/21/1997
Habitrol (Nicotine) Transdermal System Novartis DDMAC 7/10/1997 6/3/1998
Humatrope (Somatropin rDNA Origin) Eli Lilly DDMAC 7/11/1997 6/3/1998
Lovenox (Enoxaprin Sodium) Rhone-Poulenc Rorer DDMAC 7/18/1997 6/3/1998
Monurol (Fosfomycin Tromethamine) Sachet Forest Laboratories DDMAC 7/31/1997 6/3/1998
Orphenadrine Citrate, Aspirin and Caffeine tablets Bristol-Myers Squibb DDMAC 7/2/1997 7/21/1997
Zocor (simvastatin) Merck & Co., Inc. DDMAC 7/2/1997 7/21/1997
Rowasa (mesalamine) rectal suspension enema Solvay Pharmaceuticals DDMAC 7/14/1997 7/21/1997
Vancenase, Vancenase AQ, Vanceril Schering Corporation DDMAC 7/31/1997 9/22/1997
Viramune (Nevirapone) Boehringer Ingelheim DDMAC 7/2/1997 6/3/1998

August 1997
Acular (Ketorlac Tromethamine) Hoffman-LaRoche DDMAC 8/18/1997 6/2/1998
Biaxin (Clarithromycin) Abbott Laboratories DDMAC 8/7/1997 6/2/1998
Claritin (Loratadine) Tablets Schering DDMAC 8/19/1997 6/3/1998
Coumadin (warfarin sodium tablets, USP) crystalline Dupont Merck Pharmaceutical Company DDMAC 8/26/1997 9/22/1997
Crolom (Cromolyn Sodium Ophthalmic Solution) Bausch & Lomb DDMAC 8/15/1997 6/2/1998
"e-LUDES" Spectrum Group, LLC DLNDC 8/29/1997 9/24/1997
Estrasorb (Estradiol Micellar Nanoparticles) Novavax DDMAC 8/12/1997 6/2/1998
Flomax (Tamsulosin HCl) Boehringer Ingelheim DDMAC 8/1/1997 6/2/1998
Fosamax Merck DDMAC 8/6/1997 4/19/2007
Fragmin (Dalteparin Sodium) Pharmacia & Upjohn DDMAC 8/7/1997 6/2/1998
Glucophage (Metformin HCl) Bristol-Myers Squibb DDMAC 8/7/1997 6/2/1998
"Herbal Advanced Formula Hextasy" International Oddities DNNCD 8/29/1997 9/24/1997
"Herbal Ecstacy" Global World Media Corp. DLNDC 8/29/1997 9/24/1997
Lorabid (Loracarbef) Eli Lilly DDMAC 8/14/1997 6/2/1998
Lotrel (Amlodipine Besylate/Benazepril HCl) Novartis DDMAC 8/18/1997 6/2/1998
Myoview (kit for the preparation of Technetium Tc99m Tetrofosmin Injection) Amersham Healthcare, Inc. DDMAC 8/21/1997 9/22/1997
Oros (Oxybutynin Chloride) Alza Corporation DDMAC 8/28/1997 6/3/1998
ProcalAmine McGaw DDMAC 8/15/1997 6/2/1998
Synthroid Knoll Pharmaceuticals DDMAC 8/1/1997 6/2/1998
Tazarac (Tazarotene) Topical Gel Allergan DDMAC 8/28/1997 6/3/1998
Viroptic Ophthalmic Solution Monarch Pharmaceuticals DDMAC 8/7/1997 6/2/1998
Warfarin Sodium Tablets, USP Barr Laboratories DDMAC 8/26/1997 9/22/1997
"X TABLETS" Hit Products, Inc. DLNDC 8/29/1997 9/24/1997
Xenical (Orlistat) Capsules Hoffman-La Roche DDMAC 8/21/1997 6/3/1998
Zithromax (Azithromycin) Capsules/Suspension Pfizer Inc. DDMAC 8/25/1997 6/2/1998

September 1997
Betimol (Timolol Ophthalmic Solution) Leiras DDMAC 9/2/1997 5/29/1998
Claritin (Loratadine) Tablets Schering DDMAC 9/8/1997 5/29/1998
DiltiaXT (Diltiazem HCl) Andrx Pharmaceuticals DDMAC 9/16/1997 5/29/1998
Flonase (Fluticasone Propionate) Nasal Spray Glaxo Wellcome DDMAC 9/11/1997 5/29/1998
Imdur (Isosorbide Mononitrate) Key Pharmaceuticals DDMAC 9/2/1997 5/29/1998
Integrilin (Intrifiban) COR Therapeutics DDMAC 9/25/1997 5/29/1998
Ortho Tri-Cyclen (Norgestimate and Ethinyl Estradiol) R.W. Johnson DDMAC 9/24/1997 5/29/1998
Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998
Salagen (Pilocarpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998
Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997
Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998

October 1997
Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22/1998
Aerobid/Aerobid-M (flunisolide) Inhaler System Forest Laboratories DDMAC 10/15/1997 5/22/1998
Aerobid/Aerobid-M (flunisolide) Inhaler System Forest Laboratories DDMAC 10/30/1997 11/12/1997
Altace (Ramipril) Capsules Hoechst Marion Roussel DDMAC 10/27/1997 5/22/1998
Coreg (Carvedilol) Tablets SmithKline Beecham DDMAC 10/15/1997 5/22/1998
Cozaar (Losartan Potassium) Tablets and Hyzaar (Losartan Potassium-Hydrochlorothiazide) Tablets Merck DDMAC 10/20/1997 5/22/1998
Flonase (Fluticasone Propionate) Nasal Spray Glaxo Wellcome DDMAC 10/10/1997 5/22/1998
Flovent (fluticasone propionate) Inhalation Aerosol Glaxo Wellcome DDMAC 10/30/1997 11/12/1997
Habitrol (Nicotine Transdermal System) Novartis Consumer Health DDMAC 10/9/1997 5/22/1998
Inspection (IRB) Baptist Medical Center-Montclair DSI 10/23/1997 6/5/1998
Levothroid (Levothyroxine Sodium Tablets) Forest Laboratories DDMAC 10/16/1997 5/22/1998
Macrobid (nitrofurantoin monohydrate/macrocrytals) Procter & Gamble Pharmaceuticals DDMAC 10/28/1997 11/12/1997
Primacor (Milrinone Lactate Injection) Sanofi Pharmaceuticals DDMAC 10/27/1997 5/22/1998
Pulmicort Turbuhaler (Budesonide Inhalation Powder) Astra USA DDMAC 10/21/1997 5/22/1998
Travasol (Amino Acid) Injections in Dextrose Injection in Quick Mix Dual Chamber Container Baxter Healthcare DDMAC 10/21/1997 5/22/1998

November 1997
Acular (Ketorolac Tromethamine) Hoffman-LaRoche DDMAC 11/18/1997 5/21/1998
Allegra (Fexofendadine HCl) Capsules Hoechst Marion Roussel DDMAC 11/26/1997 5/21/1998
Coreg (Carvedilol) Tablets SmithKline Beecham DDMAC 11/20/1997 5/21/1998
Covera-HS (verapamil hydrochloride) Extended Release Tablets Controlled-Onset G.D. Searle DDMAC 11/21/1997 11/26/1997
Evista (Raloxifene HCl) Eli Lilly DDMAC 11/26/1997 5/21/1998
Pravachol (Pravastatin Sodium) Tablets Bristol-Myers Squibb DDMAC 11/26/1997 5/21/1998
Prevacid (Lansoprazole) Delayed-Release Capsules TAP Holdings DDMAC 11/7/1997 5/21/1998
Raxar (Grepafloxacin HCl) Tablets GlaxoWellcome DDMAC 11/25/1997 5/21/1998
Soma (Carisoprodol) Tablets/Soma Compound Wallace Laboratories DDMAC 11/14/1997 5/21/1998
Vancenase (Beclomethasone Dipropionate) Pockethaler Nasal Inhaler Schering DDMAC 11/7/1997 5/21/1998

December 1997
Fortovase (Saquinavir) Capsules Hoffman-La Roche DDMAC 12/3/1997 5/21/1998
Inspection Guangdong Pharmaceutical Factory DMPQ 12/10/1997 12/17/1997
Inspection St. Francis Hospital DSI 12/3/1997 6/5/1998
Inspection Tianjin Pharmaceutical DMPQ 12/30/1997 6/5/1998
Ipratropium Bromide Inhalation Solution 0.02% Roxane DDMAC 12/22/1997 5/21/1998
Merrem I.V. (Meropenem for Injection) Zeneca DDMAC 12/4/1997 5/21/1998
Normiflo (Ardeparin Sodium) Injection Wyeth-Ayerst Laboratories DDMAC 12/29/1997 5/21/1997
Pulmicort Turbuhaler (Budesonide Inhalation Powder) Astra USA DDMAC 12/12/1997 5/21/1998
Requip (ropinirole HCl) Tablets Smithkline Beecham DDMAC 12/3/1997 5/21/1998

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