Drugs

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.

ProductCompanyDivisionReleasedPosted

January

AcuTect (kit for the preparation of Technetium Tc99m Apctide injection)Diatide, Inc.DDMAC1/5/19991/14/1999
Azopt (brinzolamide ophthalmic suspension)Alcon LaboratoriesDDMAC1/5/19991/11/1999
Evista (raloxifene HCl)Eli LillyDDMAC1/12/19991/20/1999
Lescol (fluvastatin sodium) capsules-Warning LetterNovartisDDMAC1/21/19991/21/1999
Lotrel (amlodipine beslylate/benzepril HCl) capsulesNovartisDDMAC1/19/19991/26/1999
Nasonex (mometasone furoate monohydrate) Nasal SpraySchering CorporationDDMAC1/5/19991/11/1999
Nolvadex (tamoxifen citrate)ZenecaDDMAC1/22/19992/17/1999
Novocol Pharmaceutical Site Inspection (Warning Letter)Novocol PharmaceuticalDMPQ1/8/19991/13/1999
OratestZila, Inc.DDMAC1/28/19992/12/1999
PramlintideAmylin PharmaceuticalsDDMAC1/21/19992/25/1999
Premarin (conjugated estrogens tablets)Wyeth-AyerstDDMAC1/11/19991/14/1999
Preven Emergency Contraceptive KitGynetics Inc.DDMAC1/21/19991/26/1999
Prograf (tacrolimus) capsulesFujisawa USADDMAC1/4/19991/11/1999
Remeron (mitrazapine) tabletsOrganonDDMAC1/5/19991/14/1999
Risperdal (risperidone) tablets and oral solutionJanssen ResearchDDMAC1/5/19991/14/1999
Trivora, Zovia, Necon, Levora, Nor-QD TabletsWatson LaboratoriesDDMAC1/26/19992/12/1999

February

Arava (leflunomide) tabletsHoechst Marion RousselDDMAC2/23/19993/1/1999
Betoptic S (betaxolol HCl) Sterile Ophthalmic SuspensionAlcon LaboratoriesDDMAC2/23/19993/1/1999
Chirocaine (levobupivacaine) injectionParexel International CorporationDDMAC2/12/19995/18/1999
Coreg (carvedilol) tabletsSmithKline BeechamDDMAC2/9/19994/13/1999
Deviation from compliance with Postmarketing Adverse Experience reportingSchering AGDPDCS2/25/19993/12/1999
Ditropan (oxybutynin chloride) tabletsAlza CorporationDDMAC2/12/19994/13/1999
Levoxyl (levothryoxine sodium) tablets, USPJones Medical IndustriesDDMAC2/1/19992/12/1999
Valstar (valrubicin)Anthra PharmaceuticalsDDMAC2/16/19994/13/1999
Valtrex (valacyclovir HCl) capletsGlaxo WellcomeDDMAC2/1/19992/12/1999

March

Avapro (irbesartan) tabletsBristol-MyersDDMAC3/31/19994/14/1999
Diprivan (propofol) injectable emulsionZeneca PharmaceuticalsDDMAC3/23/19994/14/1999
Lamisil (terbinafine HCl) tabletsNovartisDDMAC3/5/19994/14/1999
Migranal (dihydroergotamine mesylate) Nasal SprayNovartisDDMAC3/1/19994/14/1999
Neoral (Cyclosporine) capsules and oral solutionNovartisDDMAC3/11/19994/14/1999
Prohance (gadoteridol) injectionBracco DiagnosticsDDMAC3/31/19994/14/1999
SonoRx (simethicone coated cellulose suspension)Bracco DiagnosticsDDMAC3/31/19994/14/1999
Trovan (trovafloxacin/alatrofloxacin) tablets/injectionPfizerDDMAC3/5/19994/14/1999
Xopenex (levalbuterol HCl) inhalation solutionSepracorDDMAC3/26/19994/14/1999
Zofran (Ondansetron Hydrochloride) InjectionGlaxoWellcomeDDMAC3/9/19993/29/1999

April

Abarelix-DepotAmgen, Inc.DDMAC4/1/19995/18/1999
Alphagan (brimonidine tartrate) ophthalmic solutionAllerganDDMAC4/15/19995/18/1999
Avandia (rosiglitazone maleate) tabletsSmithKline Beecham PharmaceuticalsDDMAC4/28/19995/18/1999
Cardura (doxazosin mesylate) tabletsPfizerDDMAC4/2/19994/14/1999
Ciloxan (ciprofloxacin HCl)Alcon LaboratoriesDDMAC4/15/19995/18/1999
Cipro (ciprofloxacin) tabletsBayer Pharm.DDMAC4/2/19994/14/1999
ClinCon Monitoring InspectionClinCon Research Inc.DSI4/9/19995/21/1999
Combivir TabletsGlaxo WellcomeDDMAC4/23/19995/18/1999
Detrol (tolterodine tartrate) tabletsPharmacia & UpjohnDDMAC4/13/19995/18/1999
Ditropan XL (oxybutynin chloride) tabletsAlza CorporationDDMAC4/2/19994/14/1999
Livostin (levocabastine HCl) ophthalmic suspensionCiba VisionDDMAC4/6/19994/14/1999
Lovenox (enoxaparin sodium) injectionRhone-Poulenc RorerDDMAC4/8/19996/8/1999
Magnevist (gadopentetate dimeglumine) injectionBerlex LaboratoriesDDMAC4/15/19995/18/1999
MD-Gastroview (diatrizoate meglumine and diatrizoate sodium solution)MallinckrodtDDMAC4/15/19995/18/1999
Micardis (telmisartan) tabletsBoehringer IngelheimDDMAC4/16/19995/18/1999
MiraLax (polyethylene glycol 3350, NF Powder)Braintree LaboratoriesDDMAC4/1/19994/14/1999
Serostim (somatropin) for injectionSerono LaboratoriesDDMAC4/27/19995/18/1999
Suprane (desflurane, USP)Baxter Pharmaceutical ProductsDDMAC4/19/19995/18/1999
TobraDex (tobramycin and dexamethsone) sterile ophthalmic suspensionAlconDDMAC4/16/19995/18/1999
Zemuron (recuronium bromide)OrganonDDMAC4/19/19995/18/1999

May

Bioresearch Monitoring Program Inspection-Warning LetterBruce Ettinger, M.D.DSI5/19/19997/8/1999
Bioresearch Monitoring Program-Warning LetterResearch Across AmericaDSI5/25/199910/1/1999
Bioresearch Monitoring Program Inspection-Warning LetterRush-Presbyterian-St. Luke's Medical CenterDSI5/19/19996/8/1999
Embeline E (clobetasol propianate cream emollient)HealthpointDDMAC5/20/19995/24/1999
Ergomar Sublingual Tablets (ergotamine tartate)Lotus Biochemical CorporationDDMAC5/14/19996/1/1999
Estrostep (norethindrone acetate and ethinyl estradiol) tabletsParke-DavisDDMAC5/5/19995/18/1999
InspectionHarvard Scientific CorpDSI5/18/19996/8/1999
Leustatin (cladribine)R.W. Johnson Pharmaceuticals Research InstitutueDDMAC5/10/19995/19/1999
Prilosec (omeprazole) plus BiaxinAstra PharmaceuticalsDDMAC5/21/19995/24/1999
Rhinocort (budesonide) nasal inhalerAstra PharmaceuticalsDDMAC5/5/19995/18/1999
Seroquel (quetiapine fumarate) tabletsZeneca PharmaceuticalsDDMAC5/6/19995/18/1999
Site Inspection-Warning LetterEli Lilly Italia S.p.A.DMPQ5/28/19996/8/1999
Xopenex (levalbuterol HCl) inhalation solutionSepracor Inc.DDMAC5/21/19996/1/1999

June

Agenerase (amprenavir) Glaxo WellcomeDDMAC6/4/19996/9/1999
Avandia (rosiglitazone maleate) tabletsSmithKline BeechamDDMAC6/29/19997/1/1999
Lipitor (atrovastatin calcium) tabletsParke-DavisDDMAC6/22/19996/29/1999
Navelbine (vinorelbine) for injectionGlaxo WellcomeDDMAC6/21/19998/6/1999
Site Inspection-Warning LetterSolvay PharmaceuticalsDMPQ6/23/19997/2/1999
Vanceril 42 mcg (beclomethasone dipropionate) inhalation aerosolSchering CorporationDDMAC6/14/19996/21/1999

July

Adefovir dipivoxilGilead SciencesDDMAC7/16/199912/20/1999
Carnitor (levocarnitine)Sigma-Tau PharmaceuticalsDDMAC7/15/19998/12/1999
Crixivan (indinavir sulfate) tabletsMerckDDMAC7/2/19997/8/1999
Fosamax (alendronate sodium) and Vioxx (rofecoxib)MerckDDMAC7/16/19998/12/1999
Rebetron Combination TherapySchering CorporationDDMAC7/15/19992/29/2000
Site Inspection-Warning LetterPharmaKineticsDSI7/27/19998/20/1999
Tapazole (methimazole)Eli Lilly and CompanyDDMAC7/2/19997/8/1999
Xenical (orlistat tetrahydrolipstatin)Hoffman-La RocheDDMAC7/19/19998/12/1999

August

Flonase (fluticasone propionate) nasal sprayGlaxo WellcomeDDMAC8/18/199912/20/1999
Liquid Deprenyl Citrate-Warning LetterDiscovery ExperimentalDLNDC8/16/19998/20/1999
Phoslo (calcium acetate) tabletsBraintree LaboratoriesDDMAC8/1/19999/27/1999

September

Anadrol-50 (oxymetholone) tablets-Warning LetterUnimed Pharmaceuticals, Inc.DDMAC9/1/19999/9/1999
Arimidex (anastrozole) tabletsZeneca PharmaceuticalsDDMAC9/27/199910/26/1999
Bactroban Nasal (calcium mupirocin)SmithKline BeechamDDMAC9/9/19999/27/1999
Camptosar Injection (irinotecan HCL)Pharmacia and UpjohnDDMAC9/9/19999/27/1999
Cleocin Vaginal Ovules (clindamycin phosphate) vaginal suppositoryPharmacia and UpjohnDDMAC9/22/199912/20/1999
Diovan (valsartan) capsulesNovartisDDMAC9/23/199910/4/1999
Flonase (fluticasone propionate) nasal sprayGlaxoWellcomeDDMAC9/17/199912/20/1999
GBC-590SafeScienceDDMAC9/10/19992/29/2000
Ipratropium Bromide Inhalation Solution-Warning LetterDey LaboratoriesDDMAC9/1/19999/9/1999
Lescol (fluvastatin sodium) capsulesNovartisDDMAC9/22/199910/4/1999
Plendil (felodipine) extended-release tabletsAstraZenecaDDMAC9/23/199910/6/1999
Site inspection-Warning LetterLong March PharmaceuticalsDMPQ9/7/199910/1/1999
Site inspection-Warning LetterSpecialties SeptodontDMPQ9/24/199912/20/1999

October

Arthrotec (diclofenac Na/misoprostol) tabletsG.D. SearleDDMAC10/13/199912/15/1999
Atacand (candesartan cilextil) tabletsAstraZenecaDDMAC10/28/199912/15/1999
Baycol (cerivastatin sodium)BayerDDMAc10/25/199912/15/1999
Brevibloc (esmolol hydrochloride) injectionBaxterDDMAC10/1/199912/15/1999
Celebrex (celecoxib) capsulesG.D. SearleDDMAC10/6/199912/15/1999
Claritin (loratadine) tabletsSchering CorporationDDMAC10/8/199912/15/1999
Cytomel (liothyronine sodium) tabletsJoes Pharma IncorporatedDDMAC10/28/199912/15/1999
EpiPen and EpiPen Jr. (epinephrine auto-injector)Dey LaboratoriesDDMAC10/6/199912/15/1999
Hydrea (hydroxyurea) capsules and Droxia (hydroxyurea) capsules-Warning LetterBristol-Myers SquibbDDMAC10/27/199911/9/1999
Xenical (orlistat) capsulesHoffman-La RocheDDMAC10/6/199910/26/1999

November

Adenoscan (adenosine)Fujisawa HealtchareDDMAC11/29/19992/29/2000
Aloprim (allopurinol sodium) for injectionNabiDDMAC11/2/199912/15/1999
Astelin (azelastine HCl) Nasal SprayCarter-WallaceDDMAC11/12/199912/15/1999
Flovent (fluticasone propionate) inhalation aerosolGlaxo WellcomeDDMAC11/30/19992/2/2000
Lidoderm (lidocaine patch 5%)Endo PharmaceuticalsDDMAC11/24/19992/29/2000
MUSE (alprostadil) urethral suppositoryVIVUSDDMAC11/3/199912/15/1999
Relenza (zanamivir for inhalation)Glaxo Wellcome Inc.DDMAC11/23/19991/11/2000
Site Inspection-Warning LetterWIL Research LaboratoriesDSI11/26/199912/3/1999
Sporanox (itraconazole) capsulesJanssen PharmaceuticaDDMAC11/9/199912/15/1999
Tambocor (flecainide acetate) tablets3M PharmaceuticalsDDMAC11/1/199912/15/1999

December

Allegra (fexofenadine HCl) capsulesHoechst Marion RoussleDDMAC12/6/19992/29/2000
Avelox (moxifloxacin hydrochloride) tabletsBayer CorporationDDMAC12/15/199912/16/1999
Site Inspection-Warning LetterCoulston FoundationDSI12/22/19991/6/2000
Vioxx (rofecoxib) tabletsMerck & CoDDMAC12/6/19992/29/2000
Zydone (hydrocodone bitartrate and acetaminophen) tabletsEndo PharmaceuticalsDDMAC12/1/19992/2/2000

 

 

 

Page Last Updated: 05/05/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English