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Drugs
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Warning Letters 1999
1999 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 links for each month to view the letters in Adobe Acrobat format.
| Product | Company | Division | Released | Posted |
|---|---|---|---|---|
|
January |
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| AcuTect (kit for the preparation of Technetium Tc99m Apctide injection) | Diatide, Inc. | DDMAC | 1/5/1999 | 1/14/1999 |
| Azopt (brinzolamide ophthalmic suspension) | Alcon Laboratories | DDMAC | 1/5/1999 | 1/11/1999 |
| Evista (raloxifene HCl) | Eli Lilly | DDMAC | 1/12/1999 | 1/20/1999 |
| Lescol (fluvastatin sodium) capsules-Warning Letter | Novartis | DDMAC | 1/21/1999 | 1/21/1999 |
| Lotrel (amlodipine beslylate/benzepril HCl) capsules | Novartis | DDMAC | 1/19/1999 | 1/26/1999 |
| Nasonex (mometasone furoate monohydrate) Nasal Spray | Schering Corporation | DDMAC | 1/5/1999 | 1/11/1999 |
| Nolvadex (tamoxifen citrate) | Zeneca | DDMAC | 1/22/1999 | 2/17/1999 |
| Novocol Pharmaceutical Site Inspection (Warning Letter) | Novocol Pharmaceutical | DMPQ | 1/8/1999 | 1/13/1999 |
| Oratest | Zila, Inc. | DDMAC | 1/28/1999 | 2/12/1999 |
| Pramlintide | Amylin Pharmaceuticals | DDMAC | 1/21/1999 | 2/25/1999 |
| Premarin (conjugated estrogens tablets) | Wyeth-Ayerst | DDMAC | 1/11/1999 | 1/14/1999 |
| Preven Emergency Contraceptive Kit | Gynetics Inc. | DDMAC | 1/21/1999 | 1/26/1999 |
| Prograf (tacrolimus) capsules | Fujisawa USA | DDMAC | 1/4/1999 | 1/11/1999 |
| Remeron (mitrazapine) tablets | Organon | DDMAC | 1/5/1999 | 1/14/1999 |
| Risperdal (risperidone) tablets and oral solution | Janssen Research | DDMAC | 1/5/1999 | 1/14/1999 |
| Trivora, Zovia, Necon, Levora, Nor-QD Tablets | Watson Laboratories | DDMAC | 1/26/1999 | 2/12/1999 |
|
February |
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| Arava (leflunomide) tablets | Hoechst Marion Roussel | DDMAC | 2/23/1999 | 3/1/1999 |
| Betoptic S (betaxolol HCl) Sterile Ophthalmic Suspension | Alcon Laboratories | DDMAC | 2/23/1999 | 3/1/1999 |
| Chirocaine (levobupivacaine) injection | Parexel International Corporation | DDMAC | 2/12/1999 | 5/18/1999 |
| Coreg (carvedilol) tablets | SmithKline Beecham | DDMAC | 2/9/1999 | 4/13/1999 |
| Deviation from compliance with Postmarketing Adverse Experience reporting | Schering AG | DPDCS | 2/25/1999 | 3/12/1999 |
| Ditropan (oxybutynin chloride) tablets | Alza Corporation | DDMAC | 2/12/1999 | 4/13/1999 |
| Levoxyl (levothryoxine sodium) tablets, USP | Jones Medical Industries | DDMAC | 2/1/1999 | 2/12/1999 |
| Valstar (valrubicin) | Anthra Pharmaceuticals | DDMAC | 2/16/1999 | 4/13/1999 |
| Valtrex (valacyclovir HCl) caplets | Glaxo Wellcome | DDMAC | 2/1/1999 | 2/12/1999 |
|
March |
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| Avapro (irbesartan) tablets | Bristol-Myers | DDMAC | 3/31/1999 | 4/14/1999 |
| Diprivan (propofol) injectable emulsion | Zeneca Pharmaceuticals | DDMAC | 3/23/1999 | 4/14/1999 |
| Lamisil (terbinafine HCl) tablets | Novartis | DDMAC | 3/5/1999 | 4/14/1999 |
| Migranal (dihydroergotamine mesylate) Nasal Spray | Novartis | DDMAC | 3/1/1999 | 4/14/1999 |
| Neoral (Cyclosporine) capsules and oral solution | Novartis | DDMAC | 3/11/1999 | 4/14/1999 |
| Prohance (gadoteridol) injection | Bracco Diagnostics | DDMAC | 3/31/1999 | 4/14/1999 |
| SonoRx (simethicone coated cellulose suspension) | Bracco Diagnostics | DDMAC | 3/31/1999 | 4/14/1999 |
| Trovan (trovafloxacin/alatrofloxacin) tablets/injection | Pfizer | DDMAC | 3/5/1999 | 4/14/1999 |
| Xopenex (levalbuterol HCl) inhalation solution | Sepracor | DDMAC | 3/26/1999 | 4/14/1999 |
| Zofran (Ondansetron Hydrochloride) Injection | GlaxoWellcome | DDMAC | 3/9/1999 | 3/29/1999 |
|
April |
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| Abarelix-Depot | Amgen, Inc. | DDMAC | 4/1/1999 | 5/18/1999 |
| Alphagan (brimonidine tartrate) ophthalmic solution | Allergan | DDMAC | 4/15/1999 | 5/18/1999 |
| Avandia (rosiglitazone maleate) tablets | SmithKline Beecham Pharmaceuticals | DDMAC | 4/28/1999 | 5/18/1999 |
| Cardura (doxazosin mesylate) tablets | Pfizer | DDMAC | 4/2/1999 | 4/14/1999 |
| Ciloxan (ciprofloxacin HCl) | Alcon Laboratories | DDMAC | 4/15/1999 | 5/18/1999 |
| Cipro (ciprofloxacin) tablets | Bayer Pharm. | DDMAC | 4/2/1999 | 4/14/1999 |
| ClinCon Monitoring Inspection | ClinCon Research Inc. | DSI | 4/9/1999 | 5/21/1999 |
| Combivir Tablets | Glaxo Wellcome | DDMAC | 4/23/1999 | 5/18/1999 |
| Detrol (tolterodine tartrate) tablets | Pharmacia & Upjohn | DDMAC | 4/13/1999 | 5/18/1999 |
| Ditropan XL (oxybutynin chloride) tablets | Alza Corporation | DDMAC | 4/2/1999 | 4/14/1999 |
| Livostin (levocabastine HCl) ophthalmic suspension | Ciba Vision | DDMAC | 4/6/1999 | 4/14/1999 |
| Lovenox (enoxaparin sodium) injection | Rhone-Poulenc Rorer | DDMAC | 4/8/1999 | 6/8/1999 |
| Magnevist (gadopentetate dimeglumine) injection | Berlex Laboratories | DDMAC | 4/15/1999 | 5/18/1999 |
| MD-Gastroview (diatrizoate meglumine and diatrizoate sodium solution) | Mallinckrodt | DDMAC | 4/15/1999 | 5/18/1999 |
| Micardis (telmisartan) tablets | Boehringer Ingelheim | DDMAC | 4/16/1999 | 5/18/1999 |
| MiraLax (polyethylene glycol 3350, NF Powder) | Braintree Laboratories | DDMAC | 4/1/1999 | 4/14/1999 |
| Serostim (somatropin) for injection | Serono Laboratories | DDMAC | 4/27/1999 | 5/18/1999 |
| Suprane (desflurane, USP) | Baxter Pharmaceutical Products | DDMAC | 4/19/1999 | 5/18/1999 |
| TobraDex (tobramycin and dexamethsone) sterile ophthalmic suspension | Alcon | DDMAC | 4/16/1999 | 5/18/1999 |
| Zemuron (recuronium bromide) | Organon | DDMAC | 4/19/1999 | 5/18/1999 |
|
May |
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| Bioresearch Monitoring Program Inspection-Warning Letter | Bruce Ettinger, M.D. | DSI | 5/19/1999 | 7/8/1999 |
| Bioresearch Monitoring Program-Warning Letter | Research Across America | DSI | 5/25/1999 | 10/1/1999 |
| Bioresearch Monitoring Program Inspection-Warning Letter | Rush-Presbyterian-St. Luke's Medical Center | DSI | 5/19/1999 | 6/8/1999 |
| Embeline E (clobetasol propianate cream emollient) | Healthpoint | DDMAC | 5/20/1999 | 5/24/1999 |
| Ergomar Sublingual Tablets (ergotamine tartate) | Lotus Biochemical Corporation | DDMAC | 5/14/1999 | 6/1/1999 |
| Estrostep (norethindrone acetate and ethinyl estradiol) tablets | Parke-Davis | DDMAC | 5/5/1999 | 5/18/1999 |
| Inspection | Harvard Scientific Corp | DSI | 5/18/1999 | 6/8/1999 |
| Leustatin (cladribine) | R.W. Johnson Pharmaceuticals Research Institutue | DDMAC | 5/10/1999 | 5/19/1999 |
| Prilosec (omeprazole) plus Biaxin | Astra Pharmaceuticals | DDMAC | 5/21/1999 | 5/24/1999 |
| Rhinocort (budesonide) nasal inhaler | Astra Pharmaceuticals | DDMAC | 5/5/1999 | 5/18/1999 |
| Seroquel (quetiapine fumarate) tablets | Zeneca Pharmaceuticals | DDMAC | 5/6/1999 | 5/18/1999 |
| Site Inspection-Warning Letter | Eli Lilly Italia S.p.A. | DMPQ | 5/28/1999 | 6/8/1999 |
| Xopenex (levalbuterol HCl) inhalation solution | Sepracor Inc. | DDMAC | 5/21/1999 | 6/1/1999 |
|
June |
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| Agenerase (amprenavir) | Glaxo Wellcome | DDMAC | 6/4/1999 | 6/9/1999 |
| Avandia (rosiglitazone maleate) tablets | SmithKline Beecham | DDMAC | 6/29/1999 | 7/1/1999 |
| Lipitor (atrovastatin calcium) tablets | Parke-Davis | DDMAC | 6/22/1999 | 6/29/1999 |
| Navelbine (vinorelbine) for injection | Glaxo Wellcome | DDMAC | 6/21/1999 | 8/6/1999 |
| Site Inspection-Warning Letter | Solvay Pharmaceuticals | DMPQ | 6/23/1999 | 7/2/1999 |
| Vanceril 42 mcg (beclomethasone dipropionate) inhalation aerosol | Schering Corporation | DDMAC | 6/14/1999 | 6/21/1999 |
|
July |
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| Adefovir dipivoxil | Gilead Sciences | DDMAC | 7/16/1999 | 12/20/1999 |
| Carnitor (levocarnitine) | Sigma-Tau Pharmaceuticals | DDMAC | 7/15/1999 | 8/12/1999 |
| Crixivan (indinavir sulfate) tablets | Merck | DDMAC | 7/2/1999 | 7/8/1999 |
| Fosamax (alendronate sodium) and Vioxx (rofecoxib) | Merck | DDMAC | 7/16/1999 | 8/12/1999 |
| Rebetron Combination Therapy | Schering Corporation | DDMAC | 7/15/1999 | 2/29/2000 |
| Site Inspection-Warning Letter | PharmaKinetics | DSI | 7/27/1999 | 8/20/1999 |
| Tapazole (methimazole) | Eli Lilly and Company | DDMAC | 7/2/1999 | 7/8/1999 |
| Xenical (orlistat tetrahydrolipstatin) | Hoffman-La Roche | DDMAC | 7/19/1999 | 8/12/1999 |
|
August |
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| Flonase (fluticasone propionate) nasal spray | Glaxo Wellcome | DDMAC | 8/18/1999 | 12/20/1999 |
| Liquid Deprenyl Citrate-Warning Letter | Discovery Experimental | DLNDC | 8/16/1999 | 8/20/1999 |
| Phoslo (calcium acetate) tablets | Braintree Laboratories | DDMAC | 8/1/1999 | 9/27/1999 |
|
September |
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| Anadrol-50 (oxymetholone) tablets-Warning Letter | Unimed Pharmaceuticals, Inc. | DDMAC | 9/1/1999 | 9/9/1999 |
| Arimidex (anastrozole) tablets | Zeneca Pharmaceuticals | DDMAC | 9/27/1999 | 10/26/1999 |
| Bactroban Nasal (calcium mupirocin) | SmithKline Beecham | DDMAC | 9/9/1999 | 9/27/1999 |
| Camptosar Injection (irinotecan HCL) | Pharmacia and Upjohn | DDMAC | 9/9/1999 | 9/27/1999 |
| Cleocin Vaginal Ovules (clindamycin phosphate) vaginal suppository | Pharmacia and Upjohn | DDMAC | 9/22/1999 | 12/20/1999 |
| Diovan (valsartan) capsules | Novartis | DDMAC | 9/23/1999 | 10/4/1999 |
| Flonase (fluticasone propionate) nasal spray | GlaxoWellcome | DDMAC | 9/17/1999 | 12/20/1999 |
| GBC-590 | SafeScience | DDMAC | 9/10/1999 | 2/29/2000 |
| Ipratropium Bromide Inhalation Solution-Warning Letter | Dey Laboratories | DDMAC | 9/1/1999 | 9/9/1999 |
| Lescol (fluvastatin sodium) capsules | Novartis | DDMAC | 9/22/1999 | 10/4/1999 |
| Plendil (felodipine) extended-release tablets | AstraZeneca | DDMAC | 9/23/1999 | 10/6/1999 |
| Site inspection-Warning Letter | Long March Pharmaceuticals | DMPQ | 9/7/1999 | 10/1/1999 |
| Site inspection-Warning Letter | Specialties Septodont | DMPQ | 9/24/1999 | 12/20/1999 |
|
October |
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| Arthrotec (diclofenac Na/misoprostol) tablets | G.D. Searle | DDMAC | 10/13/1999 | 12/15/1999 |
| Atacand (candesartan cilextil) tablets | AstraZeneca | DDMAC | 10/28/1999 | 12/15/1999 |
| Baycol (cerivastatin sodium) | Bayer | DDMAc | 10/25/1999 | 12/15/1999 |
| Brevibloc (esmolol hydrochloride) injection | Baxter | DDMAC | 10/1/1999 | 12/15/1999 |
| Celebrex (celecoxib) capsules | G.D. Searle | DDMAC | 10/6/1999 | 12/15/1999 |
| Claritin (loratadine) tablets | Schering Corporation | DDMAC | 10/8/1999 | 12/15/1999 |
| Cytomel (liothyronine sodium) tablets | Joes Pharma Incorporated | DDMAC | 10/28/1999 | 12/15/1999 |
| EpiPen and EpiPen Jr. (epinephrine auto-injector) | Dey Laboratories | DDMAC | 10/6/1999 | 12/15/1999 |
| Hydrea (hydroxyurea) capsules and Droxia (hydroxyurea) capsules-Warning Letter | Bristol-Myers Squibb | DDMAC | 10/27/1999 | 11/9/1999 |
| Xenical (orlistat) capsules | Hoffman-La Roche | DDMAC | 10/6/1999 | 10/26/1999 |
|
November |
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| Adenoscan (adenosine) | Fujisawa Healtchare | DDMAC | 11/29/1999 | 2/29/2000 |
| Aloprim (allopurinol sodium) for injection | Nabi | DDMAC | 11/2/1999 | 12/15/1999 |
| Astelin (azelastine HCl) Nasal Spray | Carter-Wallace | DDMAC | 11/12/1999 | 12/15/1999 |
| Flovent (fluticasone propionate) inhalation aerosol | Glaxo Wellcome | DDMAC | 11/30/1999 | 2/2/2000 |
| Lidoderm (lidocaine patch 5%) | Endo Pharmaceuticals | DDMAC | 11/24/1999 | 2/29/2000 |
| MUSE (alprostadil) urethral suppository | VIVUS | DDMAC | 11/3/1999 | 12/15/1999 |
| Relenza (zanamivir for inhalation) | Glaxo Wellcome Inc. | DDMAC | 11/23/1999 | 1/11/2000 |
| Site Inspection-Warning Letter | WIL Research Laboratories | DSI | 11/26/1999 | 12/3/1999 |
| Sporanox (itraconazole) capsules | Janssen Pharmaceutica | DDMAC | 11/9/1999 | 12/15/1999 |
| Tambocor (flecainide acetate) tablets | 3M Pharmaceuticals | DDMAC | 11/1/1999 | 12/15/1999 |
|
December |
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| Allegra (fexofenadine HCl) capsules | Hoechst Marion Roussle | DDMAC | 12/6/1999 | 2/29/2000 |
| Avelox (moxifloxacin hydrochloride) tablets | Bayer Corporation | DDMAC | 12/15/1999 | 12/16/1999 |
| Site Inspection-Warning Letter | Coulston Foundation | DSI | 12/22/1999 | 1/6/2000 |
| Vioxx (rofecoxib) tablets | Merck & Co | DDMAC | 12/6/1999 | 2/29/2000 |
| Zydone (hydrocodone bitartrate and acetaminophen) tablets | Endo Pharmaceuticals | DDMAC | 12/1/1999 | 2/2/2000 |
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