Aurobindo Pharma Limited

• LisinoprilZestril, Qbrelis · 6 products
• Ondansetron6 products
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 5 products
• BuspironeBucapsol · 5 products
• LevothyroxineTirosint, Tirosint Sol, Synthroid · 5 products
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 5 products
• CitalopramCelexa · 5 products
• SimvastatinZocor · 5 products
• GabapentinNeurontin, Gralise, Relgaabi · 5 products
• LacosamideVimpat, Motpoly XR · 5 products
• TadalafilCialis, Tadliq, Adcirca · 5 products
• MetoprololToprol XL, Lopressor, Kapspargo · 5 products
• Amitriptyline hydrochloride5 products
• Valsartan and hydrochlorothiazideDiovan Hct · 5 products
• Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 5 products
• Lurasidone hydrochlorideLatuda · 5 products
• SildenafilViagra, Vybrique, Revatio · 5 products
• Chlorpromazine hydrochloride5 products
• LevetiracetamKeppra, Spritam, Keppra XR · 5 products
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 5 products
• Benazepril hydrochlorideLotensin · 5 products
• TizanidineZanaflex, Ontralfy · 5 products
• IbuprofenIbu, Caldolor · 4 products
• PomalidomidePomalyst · 4 products
• MontelukastSingulair · 4 products
• Sunitinib malateSutent · 4 products
• Eslicarbazepine acetateAptiom · 4 products
• Cimetidine4 products
• Ezetimibe and simvastatinVytorin · 4 products
• DiclofenacZipsor, Lofena, Cambia · 4 products
• ParoxetinePaxil, Paxil CR, Brisdelle · 4 products
• Ramipril4 products
• ValsartanDiovan · 4 products
• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 4 products
• Quinapril4 products
• AzithromycinZithromax, Azasite · 4 products
• RivastigmineRivastigmine Transdermal System, Exelon · 4 products
• AtazanavirReyataz · 4 products
• Amlodipine and valsartanExforge · 4 products
• LevalbuterolXopenex HFA · 4 products
• DeflazacortJaythari, Emflaza, Kymbee · 4 products
• Nitrofurantoin4 products
• DoxazosinCardura, Cardura XL · 4 products
• EverolimusYulithira, Zortress, Afinitor · 4 products
• TorsemideSoaanz · 4 products
• RosuvastatinCrestor · 4 products
• ZiprasidoneGeodon · 4 products
• Amlodipine and olmesartan medoxomilAzor · 4 products
• AtorvastatinLipitor · 4 products
• Fluphenazine hydrochlorideFluphenazine Hydrochoride · 4 products
• CarvedilolCoreg, Coreg CR · 4 products
• Tenofovir disoproxil fumarateViread · 4 products
• NebivololBystolic · 4 products
• Dapagliflozin and metformin hydrochlorideXigduo XR · 4 products
• Emtricitabine and tenofovir disoproxil fumarateTruvada · 4 products
• Cefprozil4 products
• Efavirenz4 products
• EscitalopramLexapro · 4 products
• ArmodafinilNuvigil · 4 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
• Cefpodoxime proxetil4 products
• Risedronate4 products
• OmeprazolePrilosec · 3 products
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 3 products
• PirfenidoneEsbriet · 3 products
• Prazosin hydrochloride3 products
• DroxidopaNorthera · 3 products
• ZonisamideZonegran, Zonisade · 3 products
• Erlotinib3 products
• Isosorbide mononitrate3 products
• RufinamideBanzel · 3 products
• OxcarbazepineTrileptal, Oxtellar XR · 3 products
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 3 products
• LamivudineEpivir · 3 products
• Glyburide and metformin hydrochloride3 products
• Cefadroxil3 products
• HydrochlorothiazideInzirqo · 3 products
• Quinapril HCL and hydrochlorothiazide3 products
• Cefdinir3 products
• Perindopril erbumine3 products
• Alendronate sodiumBinosto, Fosamax · 3 products
• Levofloxacin3 products
• IrbesartanAvapro · 3 products
• FelodipineFelopdipine · 3 products
• Olmesartan medoxomilBenicar · 3 products
• FamotidinePepcid · 3 products
• ParicalcitolZemplar · 3 products
• Telmisartan and hydrochlorothiazideMicardis Hct · 3 products
• DuloxetineDrizalma Sprinkle · 3 products
• NifedipineProcardia XL · 3 products
• Chlorzoxazone3 products
• NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 3 products
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 3 products
• FurosemideLasix, Furoscix, Lasix Onyu · 3 products
• ZidovudineRetrovir · 3 products
• SumatriptanImitrex, Tosymra, Zembrace Symtouch · 3 products
• Trandolapril3 products
• AtenololTenormin · 3 products
• Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
• Losartan potassium and hydrochlorothiazideHyzaar · 3 products
• Irbesartan and hydrochlorothiazideAvalide · 3 products
• Cefixime3 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
• DofetilideTikosyn · 3 products
• Midodrine hydrochloride3 products
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 3 products
• Bisoprolol fumarate and hydrochlorothiazide3 products
• ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 3 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• Famciclovir3 products
• Fosinopril sodium3 products
• Flecainide acetate3 products
• Telmisartan3 products
• Nadolol3 products
• SpironolactoneAldactone · 3 products
• Carbidopa and levodopaCrexont, Rytary, Sinemet · 3 products
• Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 3 products
• Sulfamethoxazole and trimethoprimSulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds · 3 products
• PioglitazoneActos · 3 products
• Cefuroxime axetil3 products
• EszopicloneLunesta · 3 products
• BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 3 products
• Sacubitril and valsartanEntresto · 3 products
• DigoxinLanoxin · 3 products
• Hydroxyzine3 products
• Mycophenolate mofetilCellcept, Myhibbin · 3 products
• AcyclovirZovirax, Avaclyr · 3 products
• PitavastatinZypitamag, Livalo · 3 products
• CinacalcetSensipar · 3 products
• NiacinNiacor · 3 products
• DiazepamValium, Valtoco · 3 products
• TofacitinibXeljanz, Xeljanz XR · 3 products
• ClonazepamKlonopin · 3 products
• GlipizideGlucotrol XL · 3 products
• Meclizine hydrochloride3 products
• Clomipramine hydrochlorideAnafranil · 3 products
• Lisinopril and hydrochlorothiazideZestoretic · 3 products
• Repaglinide3 products
• Dabigatran etexilatePradaxa · 3 products
• Glimepiride3 products
• Sevelamer carbonateRenvela · 3 products
• Cilostazol2 products
• RanolazineAspruzyo Sprinkle · 2 products
• Eletriptan hydrobromideRelpax · 2 products
• DapagliflozinFarxiga · 2 products
• Pilocarpine hydrochlorideSalagen, Qlosi · 2 products
• Dicloxacillin sodium2 products
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 2 products
• Dicyclomine hydrochloride2 products
• RoflumilastZoryve, Daliresp · 2 products
• Bisoprolol fumarate2 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
• Solifenacin succinate2 products
• TeriflunomideAubagio · 2 products
• ProgesteroneCrinone, Prometrium, Endometrin · 2 products
• Fenofibric acid2 products
• Desmopressin acetateDdavp, Stimate, Desmoda · 2 products
• AllopurinolAloprim · 2 products
• Tamoxifen citrateSoltamox · 2 products
• FlucytosineAncobon · 2 products
• MethocarbamolRobaxin, Atmeksi, Tanlor · 2 products
• Varenicline tartrateChantix, Tyrvaya · 2 products
• Etodolac2 products
• AmbrisentanLetairis · 2 products
• Ampicillin2 products
• Acetazolamide2 products
• FinasteridePropecia, Proscar · 2 products
• Penicillin v potassium2 products
• Zaleplon2 products
• ValganciclovirValcyte · 2 products
• PrasugrelEffient · 2 products
• MoxifloxacinVigamox · 2 products
• LansoprazolePrevacid Solutab, Prevacid · 2 products
• ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 2 products
• NorethindroneErrin, Nora Be, Camila · 2 products
• LeflunomideArava · 2 products
• VigabatrinSabril, Vigadrone, Vigafyde · 2 products
• Estradiol and norethindrone acetateLopreeza, Combipatch (Estradiol/Norethindrone Acetate Transdermal System), Etyqa · 2 products
• Mycophenolic acidMyfortic · 2 products
• TretinoinRetin-A, Retin-A Micro, Altreno · 2 products
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 2 products
• EntecavirBaraclude · 2 products
• Silodosin2 products
• ProchlorperazineCompro · 2 products
• Betamethasone dipropionateDiprolene, Sernivo · 2 products
• Nevirapine2 products
• MeloxicamZybic, Xifyrm, Qamzova · 2 products
• Zolpidem tartrateAmbien, Ambien CR, Edluar · 2 products
• Ribavirin2 products
• Clarithromycin2 products
• Pioglitazone and metformin hydrochlorideActoplus Met · 2 products
• ModafinilProvigil · 2 products
• Fesoterodine fumarateToviaz · 2 products
• Norethindrone acetate and ethinyl estradiolJunel 21 Day, Loestrin 21 Day, Fyavolv · 2 products
• Dimethyl fumarateTecfidera · 2 products
• DarunavirPrezista · 2 products
• Sevelamer hydrochloride2 products
• Zafirlukast2 products
• ValacyclovirValtrex · 2 products
• ColchicineColcrys, Gloperba, Lodoco · 2 products
• AbacavirZiagen · 2 products
• Fosinopril sodium and hydrochlorothiazide2 products
• Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 2 products
• PermethrinElimite · 2 products
• GuanfacineIntuniv · 2 products
• Donepezil hydrochlorideAricept · 2 products
• Imatinib mesylateGleevec, Imkeldi · 2 products
• Saxagliptin2 products
• Darifenacin2 products
• VoriconazoleVfend · 2 products
• FebuxostatUloric · 2 products
• CapecitabineXeloda · 2 products
• CarisoprodolSoma · 2 products
• CarbidopaLodosyn · 1 product
• Azelastine hydrochloride1 product
• Phenoxybenzamine hydrochloride1 product
• GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 1 product
• LifitegrastXiidra · 1 product
• Entacapone1 product
• RitonavirNorvir · 1 product
• LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
• MethotrexateRasuvo, Otrexup, Trexall · 1 product
• ClobazamSympazan, Onfi · 1 product
• UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 1 product
• Sapropterin dihydrochlorideKuvan, Javygtor, Zelvysia · 1 product
• Loperamide hydrochloride1 product
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
• Lamivudine and zidovudineCombivir · 1 product
• EmtricitabineEmtriva · 1 product
• DalfampridineAmpyra · 1 product
• AnastrozoleArimidex · 1 product
• Cevimeline hydrochlorideEvoxac · 1 product
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
• NystatinNystop, Klayesta, Nyamyc · 1 product
• Econazole nitrateEcoza · 1 product
• Raloxifene hydrochlorideEvista · 1 product
• Sumatriptan and naproxen sodiumTreximet · 1 product
• LetrozoleFemara · 1 product
• PazopanibVotrient · 1 product
• Ibuprofen and famotidine1 product
• Terbinafine hydrochloride1 product
• RisperidoneUzedy, Risperdal, Risperdal M-Tab · 1 product
• Methenamine hippurate1 product
• Mometasone furoate monohydrate1 product
• EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 product
• Enalapril maleateVasotec, Epaned · 1 product
• Aminocaproic acid1 product
• Adapalene and benzoyl peroxideEpiduo Forte · 1 product
• DapsoneAczone · 1 product
• Dutasteride and tamsulosin hydrochlorideJalyn · 1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 1 product
• RamelteonRozerem · 1 product
• Tranexamic acidCyklokapron · 1 product
• Hydroxychloroquine sulfatePlaquenil, Sovuna · 1 product
• Efavirenz, emtricitabine and tenofovir disoproxil fumarate1 product
• Tamsulosin hydrochloride1 product
• Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloridePEG 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Trilyte, Peg-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride · 1 product
• Alfuzosin hydrochlorideUroxatral · 1 product
• RivaroxabanXarelto · 1 product
• Ibandronate sodium1 product
• Abacavir and lamivudine1 product
• ClopidogrelPlavix · 1 product
• BromfenacBromsite 0.075%, Prolensa · 1 product
• Tramadol hydrochloride and acetaminophen1 product
• MacitentanOpsumit · 1 product
• PyrimethamineDaraprim · 1 product
• Oseltamivir phosphateTamiflu · 1 product
• Glycerol phenylbutyrateRavicti · 1 product
• Clindamycin palmitate hydrochlorideClindamycin Palmitate Hydrochloride (Pediatric), Cleocin Pediatric · 1 product
• GemfibrozilLopid · 1 product
• Amiodarone hydrochloridePacerone, Nexterone · 1 product
• BimatoprostLumigan, Latisse, Durysta · 1 product
• Ipratropium bromide and albuterol sulfateCombivent Respimat · 1 product
• FingolimodGilenya · 1 product
• EzetimibeZetia · 1 product
• MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
• Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
• PosaconazoleNoxafil · 1 product
• PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 1 product
• Dutasteride1 product
• Tramadol hydrochlorideConzip · 1 product
• PrednisoloneOrapred ODT · 1 product
• ExemestaneAromasin · 1 product
• FosfomycinContepo · 1 product
• Icosapent ethylVascepa · 1 product
• Rabeprazole sodiumAciphex · 1 product
• Ipratropium bromideAtrovent HFA · 1 product
• Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product

2021

1. March 15, 2021 · Class II · Terminated · D-0438-2021 · Eletriptan hydrobromide

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520

2. March 15, 2021 · Class II · Terminated · D-0437-2021 · Ibuprofen

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

3. January 20, 2021 · Class II · Terminated · D-0290-2021 · Famotidine

   Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

   Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99

2020

1. August 10, 2020 · Class II · Terminated · D-1535-2020 · Sulfamethoxazole and trimethoprim

   Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

   Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in In

2. June 12, 2020 · Class II · Terminated · D-1370-2020 · Clozapine

   Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

   Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05

3. March 18, 2020 · Class II · Terminated · D-1233-2020 · Levetiracetam

   CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

   Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

4. March 18, 2020 · Class II · Terminated · D-1232-2020 · Gabapentin

   CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

   Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

5. March 18, 2020 · Class II · Terminated · D-1234-2020 · Simvastatin

   CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

   Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

6. February 7, 2020 · Class II · Terminated · D-0852-2020 · Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)

   Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie

   Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

2019

1. December 2, 2019 · Class III · Terminated · D-0789-2020 · Moxifloxacin

   Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

   Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

2. July 29, 2019 · Class III · Terminated · D-1842-2019 · Simvastatin

   Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

   Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99

2018

1. December 31, 2018 · Class II · Ongoing · D-1038-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

2. December 31, 2018 · Class II · Ongoing · D-0370-2019 · Valsartan

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.

3. December 31, 2018 · Class II · Ongoing · D-1039-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

4. December 31, 2018 · Class II · Ongoing · D-1037-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30

5. December 31, 2018 · Class II · Ongoing · D-1035-2019 · Valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90

6. December 31, 2018 · Class II · Ongoing · D-0366-2019 · Valsartan and hydrochlorothiazide

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.

7. December 31, 2018 · Class II · Ongoing · D-0364-2019 · Amlodipine and valsartan

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.

8. December 31, 2018 · Class II · Ongoing · D-0368-2019 · Valsartan and hydrochlorothiazide

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.

9. December 31, 2018 · Class II · Ongoing · D-1036-2019 · Amlodipine and valsartan

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

10. December 31, 2018 · Class II · Ongoing · D-0362-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.

11. December 31, 2018 · Class II · Ongoing · D-0361-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

12. December 31, 2018 · Class II · Ongoing · D-0365-2019 · Valsartan and hydrochlorothiazide

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.

13. December 31, 2018 · Class II · Ongoing · D-0369-2019 · Valsartan and hydrochlorothiazide

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.

14. December 31, 2018 · Class II · Ongoing · D-0363-2019 · Amlodipine and valsartan

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

15. December 31, 2018 · Class II · Ongoing · D-0367-2019 · Valsartan and hydrochlorothiazide

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.

16. November 30, 2018 · Class III · Terminated · D-0289-2019 · Amlodipine and olmesartan medoxomil

    Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30

17. February 2, 2018 · Class III · Terminated · D-0427-2018 · Metformin hydrochloride

    Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

    Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mah

2016

1. December 22, 2016 · Class II · Terminated · D-0474-2017 · Venlafaxine hydrochloride

   Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

   Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyder

2013

1. April 9, 2013 · Class III · Terminated · D-498-2013 · Lisinopril

   Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

   Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).