Apotex Corp.

• SitagliptinJanuvia, Zituvio, Brynovin · 3 productos
• NilotinibTasigna, Danziten, Cavhanza · 3 productos
• MirtazapineRemeronsoltab, Remeron · 3 productos
• Risedronate3 productos
• LevetiracetamKeppra, Spritam, Keppra XR · 3 productos
• Vilazodone hydrochlorideViibryd · 3 productos
• TofacitinibXeljanz, Xeljanz XR · 3 productos
• Dabigatran etexilatePradaxa · 3 productos
• Triamterene and hydrochlorothiazide2 productos
• SelegilineEmsam, Zelapar · 2 productos
• TicagrelorBrilinta · 2 productos
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 productos
• OfloxacinOcuflox · 2 productos
• Abiraterone acetateZytiga, Abirtega, Yonsa · 2 productos
• Zinc sulfate injection2 productos
• Cilostazol2 productos
• FenofibrateAntara, Lipofen, Tricor · 2 productos
• Ondansetron2 productos
• GlipizideGlucotrol XL · 2 productos
• Desmopressin acetate (desmopressin acetate trihydrate)2 productos
• LeflunomideArava · 2 productos
• DapagliflozinFarxiga · 2 productos
• Irinotecan hydrochlorideCamptosar, Onivyde · 2 productos
• Deferoxamine mesylateDesferal · 2 productos
• Azelastine hydrochloride2 productos
• RegadenosonLexiscan · 2 productos
• Palonosetron hydrochloridePosfrea · 2 productos
• Imatinib mesylateGleevec, Imkeldi · 2 productos
• ClopidogrelPlavix · 2 productos
• Sitagliptin and metformin hydrochlorideZituvimet XR, Zituvimet, Janumet · 2 productos
• TetrabenazineXenazine · 2 productos
• AmbrisentanLetairis · 2 productos
• Solifenacin succinate2 productos
• PrucaloprideMotegrity · 2 productos
• Ertapenem sodiumInvanz · 2 productos
• Oxaliplatin2 productos
• Brimonidine tartrateAlphagan P, Mirvaso · 2 productos
• Ipratropium bromideAtrovent HFA · 2 productos
• Mycophenolic acidMyfortic · 2 productos
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 2 productos
• Eribulin mesylateHalaven · 2 productos
• PirfenidoneEsbriet · 2 productos
• NintedanibOfev · 2 productos
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 1 producto
• BimatoprostLumigan, Latisse, Durysta · 1 producto
• Brimonidine tartrate and timolol maleateCombigan · 1 producto
• Olopatadine hydrochloride1 producto
• FingolimodGilenya · 1 producto
• MacitentanOpsumit · 1 producto
• SirolimusHyftor, Fyarro · 1 producto
• AzacitidineOnureg, Vidaza · 1 producto
• Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 producto
• Azelastine hydrochloride and fluticasone propionateDymista · 1 producto
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 producto
• RivaroxabanXarelto · 1 producto
• TigecyclineTygacil · 1 producto
• CarboplatinKyxata · 1 producto
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 producto
• Adefovir dipivoxil1 producto
• PazopanibVotrient · 1 producto
• Cisplatin1 producto
• PentoxifyllineTrental · 1 producto
• Desmopressin acetateDdavp, Stimate, Desmoda · 1 producto
• Calcitonin salmonMiacalcin · 1 producto
• TasimelteonHetlioz Lq, Hetlioz · 1 producto
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 producto
• Fluticasone propionateFluticasone Propionate Diskus, Xhance, Flovent Diskus · 1 producto
• CladribineMavenclad · 1 producto
• BromfenacBromsite 0.075%, Prolensa · 1 producto
• Balsalazide disodium1 producto
• Alfuzosin hydrochlorideUroxatral · 1 producto
• Bendamustine hydrochlorideTreanda, Vivimusta, Belrapzo · 1 producto
• Melphalan HCLIvra, Evomela · 1 producto
• DiclofenacZipsor, Lofena, Cambia · 1 producto
• MoxifloxacinVigamox · 1 producto
• Butorphanol tartrate1 producto
• Mometasone furoate (mometasone)1 producto
• BortezomibBoruzu, Velcade · 1 producto
• Ibandronate sodium1 producto
• Memantine hydrochloride1 producto
• AtropineAtropen Auto-Injector, Isopto Atropine · 1 producto
• Icosapent ethylVascepa · 1 producto
• FidaxomicinDificid · 1 producto
• Tranexamic acidCyklokapron · 1 producto
• TeriparatideForteo, Bonsity · 1 producto
• DaptomycinDapzura Rt · 1 producto
• TrabectedinYondelis, Evdi · 1 producto

2023

1. 1 de noviembre de 2023 · Clase II · En curso · D-0119-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontar

2. 1 de noviembre de 2023 · Clase II · En curso · D-0120-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apo

3. 1 de noviembre de 2023 · Clase II · En curso · D-0122-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

4. 1 de noviembre de 2023 · Clase II · En curso · D-0121-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario,

5. 26 de abril de 2023 · Clase II · Completado · D-0568-2023 · Calcitonin salmon

   Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

   Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC

6. 1 de marzo de 2023 · Clase II · Completado · D-0433-2023 · Brimonidine tartrate

   Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

   Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle,

2022

1. 3 de mayo de 2022 · Clase III · Cerrado por la FDA · D-0881-2022 · Sirolimus

   Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

   Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

2. 26 de enero de 2022 · Clase II · Cerrado por la FDA · D-0182-2024 · Fluticasone propionate

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

2021

1. 31 de marzo de 2021 · Clase II · En curso · D-0324-2021 · Guanfacine

   Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

   Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281

2. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0427-2021 · Butorphanol tartrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

3. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0425-2021 · Travoprost ophthalmic solution

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

2019

1. 22 de octubre de 2019 · Clase III · Cerrado por la FDA · D-0153-2020 · Atorvastatin

   Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

   Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

2018

1. 31 de mayo de 2018 · Clase II · Cerrado por la FDA · D-0841-2018 · Fluticasone propionate

   Presence of foreign substance: glass particles

   Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apot

2017

1. 3 de febrero de 2017 · Clase II · Cerrado por la FDA · D-0475-2017 · Cyclosporine

   Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

   CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0

2014

1. 24 de marzo de 2014 · Clase II · Cerrado por la FDA · D-1577-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

2. 24 de marzo de 2014 · Clase II · Cerrado por la FDA · D-1576-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

3. 24 de marzo de 2014 · Clase II · Cerrado por la FDA · D-1574-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

2013

1. 17 de julio de 2013 · Clase II · Cerrado por la FDA · D-017-2014 · Acyclovir

   Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

   Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.

2011

1. 15 de junio de 2011 · Clase III · Cerrado por la FDA · D-1667-2012 · Azelastine hydrochloride

   CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

   Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

2007

1. 14 de junio de 2007 · Clase II · Cerrado por la FDA · D-1661-2012 · Leflunomide

   Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

   Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9

2. 14 de junio de 2007 · Clase II · Cerrado por la FDA · D-1662-2012 · Leflunomide

   Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

   Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3

Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).