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 |