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U.S. Department of Health and Human Services

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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

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

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

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

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

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

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

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

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

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

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

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

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