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Empresa farmacéutica (etiquetadora ante la FDA)

Glenmark Pharmaceuticals Limited

Código de etiquetadora NDC: 68462

¿Qué es una etiquetadora?

La empresa cuyo nombre aparece en el envase y en el directorio de códigos nacionales de medicamentos (NDC) de la FDA. Puede fabricar el medicamento o vender uno fabricado por otra empresa. La primera parte de cada código NDC identifica a la etiquetadora.

Solo datos oficiales de la FDA

Los productos, aprobaciones y retiros vienen de la FDA (directorio NDC, Drugs@FDA, informes de retiros). Los retiros se vinculan a esta empresa por el código NDC del producto retirado.

Si tiene preguntas sobre su medicamento, hable con su médico o farmacéutico. En una emergencia, llame al 911.

De un vistazo

1Medicamentos con receta
1Productos (NDC)
1Solicitudes de la FDA
105Retiros

Medicamentos con receta

Solicitudes de la FDA de estos productos

  • ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
AprobadaSolicitudMedicamentoPatrocinador
22 de diciembre de 2023ANDA215379 Lacosamide
LACOSAMIDE		Msn

El patrocinador es la empresa titular de la solicitud ante la FDA; puede ser distinta de la etiquetadora.

Cronología de retiros

2026

  1. 23 de julio de 2026 · Clase II · En curso · D-0731-2026 · Azelaic acid

    CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

    Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

2025

  1. 30 de diciembre de 2025 · Clase II · En curso · D-0246-2026 · Ondansetron

    Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

    Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157

  2. 17 de septiembre de 2025 · Clase II · En curso · D-0662-2025 · Azelaic acid

    CGMP Deviations: Market complaints received for gritty texture (grainy)

    Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,

  3. 8 de agosto de 2025 · Clase II · En curso · D-0583-2025 · Theophylline

    Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

    Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N

  4. 7 de agosto de 2025 · Clase II · En curso · D-0577-2025 · Carvedilol

    CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

    Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Man

  5. 7 de agosto de 2025 · Clase II · En curso · D-0579-2025 · Carvedilol

    CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

    Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68

  6. 7 de agosto de 2025 · Clase II · En curso · D-0578-2025 · Carvedilol

    CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

    Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC

  7. 6 de agosto de 2025 · Clase II · En curso · D-0587-2025 · Carvedilol

    CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

    Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured

  8. 6 de agosto de 2025 · Clase II · En curso · D-0588-2025 · Carvedilol

    CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

    Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured fo

  9. 19 de mayo de 2025 · Clase III · En curso · D-0462-2025 · Ezetimibe and simvastatin

    Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

    Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceutica

Mostrar los 50 retiros anteriores

2025

  1. 15 de mayo de 2025 · Clase II · En curso · D-0452-2025 · Theophylline

    OOS results reported for the Dissolution (by UV) test.

    Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceutica

  2. 13 de marzo de 2025 · Clase II · En curso · D-0330-2025 · Lacosamide

    CGMP Deviations

    Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC

  3. 13 de marzo de 2025 · Clase II · En curso · D-0325-2025 · Pravastatin sodium

    CGMP Deviations

    Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430

  4. 13 de marzo de 2025 · Clase II · En curso · D-0341-2025 · Pravastatin sodium

    CGMP Deviations

    Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man

  5. 13 de marzo de 2025 · Clase II · En curso · D-0321-2025 · Lacosamide

    CGMP Deviations

    Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#

  6. 13 de marzo de 2025 · Clase II · En curso · D-0337-2025 · Lacosamide

    CGMP Deviations

    Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC#

  7. 13 de marzo de 2025 · Clase II · En curso · D-0324-2025 · Nitroglycerin

    CGMP Deviations

    Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N

  8. 13 de marzo de 2025 · Clase II · En curso · D-0319-2025 · Voriconazole

    CGMP Deviations

    Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#

  9. 13 de marzo de 2025 · Clase II · En curso · D-0343-2025 · Lacosamide

    CGMP Deviations

    Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 6

  10. 13 de marzo de 2025 · Clase II · En curso · D-0318-2025 · Voriconazole

    CGMP Deviations

    Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. ND

  11. 13 de marzo de 2025 · Clase II · En curso · D-0335-2025 · Ranolazine

    CGMP Deviations

    Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwa

  12. 13 de marzo de 2025 · Clase II · En curso · D-0333-2025 · Solifenacin succinate

    CGMP Deviations

    Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man

  13. 13 de marzo de 2025 · Clase II · En curso · D-0320-2025 · Gabapentin

    CGMP Deviations

    Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC

  14. 13 de marzo de 2025 · Clase II · En curso · D-0334-2025 · Teriflunomide

    CGMP Deviations

    Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. ND

  15. 13 de marzo de 2025 · Clase II · En curso · D-0336-2025 · Carvedilol

    CGMP Deviations

    Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0743

  16. 13 de marzo de 2025 · Clase II · En curso · D-0323-2025 · Rufinamide

    CGMP Deviations

    Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#

  17. 13 de marzo de 2025 · Clase II · En curso · D-0322-2025 · Frovatriptan succinate

    CGMP Deviations

    Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0

  18. 13 de marzo de 2025 · Clase II · En curso · D-0345-2025 · Saxagliptin

    CGMP Deviations

    Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured fo

  19. 13 de marzo de 2025 · Clase II · En curso · D-0340-2025 · Colesevelam hydrochloride

    CGMP Deviations

    Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah,

  20. 13 de marzo de 2025 · Clase II · En curso · D-0332-2025 · Saxagliptin

    CGMP Deviations

    Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

  21. 13 de marzo de 2025 · Clase II · En curso · D-0326-2025 · Fluphenazine hydrochloride

    CGMP Deviations

    Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah

  22. 13 de marzo de 2025 · Clase II · En curso · D-0329-2025 · Indomethacin

    CGMP Deviations

    Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ

  23. 13 de marzo de 2025 · Clase II · En curso · D-0331-2025 · Nitroglycerin

    CGMP Deviations

    Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430

  24. 13 de marzo de 2025 · Clase II · En curso · D-0344-2025 · Clindamycin

    CGMP Deviations

    Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah,

  25. 13 de marzo de 2025 · Clase II · En curso · D-0342-2025 · Diltiazem

    CGMP Deviations

    Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuti

  26. 13 de marzo de 2025 · Clase II · En curso · D-0327-2025 · Fluphenazine hydrochloride

    CGMP Deviations

    Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah

  27. 13 de marzo de 2025 · Clase II · En curso · D-0316-2025 · Propafenone hydrochloride

    CGMP Deviations

    Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals I

  28. 13 de marzo de 2025 · Clase II · En curso · D-0314-2025 · Fenofibrate

    CGMP Deviations

    Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0743

  29. 13 de marzo de 2025 · Clase II · En curso · D-0315-2025 · Propafenone hydrochloride

    CGMP Deviations

    Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals

  30. 13 de marzo de 2025 · Clase II · En curso · D-0317-2025 · Solifenacin succinate

    CGMP Deviations

    Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manuf

  31. 13 de marzo de 2025 · Clase II · En curso · D-0346-2025 · Naproxen

    CGMP Deviations

    Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ

  32. 13 de marzo de 2025 · Clase II · En curso · D-0328-2025 · Metformin hydrochloride

    CGMP Deviations

    Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, M

  33. 13 de marzo de 2025 · Clase II · En curso · D-0339-2025 · Rosuvastatin

    CGMP Deviations

    Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#

  34. 11 de marzo de 2025 · Clase II · En curso · D-0309-2025 · Chlorpromazine hydrochloride

    CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

    chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

  35. 28 de febrero de 2025 · Clase II · En curso · D-0450-2025 · Carvedilol

    CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

    Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

  36. 28 de febrero de 2025 · Clase II · En curso · D-0449-2025 · Carvedilol

    CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

    Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., US

  37. 28 de febrero de 2025 · Clase II · En curso · D-0451-2025 · Carvedilol

    CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

    Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

  38. 28 de febrero de 2025 · Clase II · En curso · D-0448-2025 · Carvedilol

    CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

    Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals

  39. 29 de enero de 2025 · Clase II · En curso · D-0232-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

  40. 29 de enero de 2025 · Clase II · En curso · D-0235-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

  41. 29 de enero de 2025 · Clase II · En curso · D-0236-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

  42. 29 de enero de 2025 · Clase II · En curso · D-0231-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

  43. 29 de enero de 2025 · Clase II · En curso · D-0233-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

  44. 29 de enero de 2025 · Clase II · En curso · D-0234-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

  45. 29 de enero de 2025 · Clase II · En curso · D-0237-2025 · Atomoxetine

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

  46. 22 de enero de 2025 · Clase II · En curso · D-0215-2025 · Carvedilol

    CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

    Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

  47. 22 de enero de 2025 · Clase II · En curso · D-0216-2025 · Carvedilol

    CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

    Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

2024

  1. 11 de diciembre de 2024 · Clase II · En curso · D-0160-2025 · Chlorpromazine hydrochloride

    CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

    chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

  2. 11 de diciembre de 2024 · Clase II · En curso · D-0159-2025 · Chlorpromazine hydrochloride

    CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

    chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

  3. 1 de noviembre de 2024 · Clase II · En curso · D-0093-2025 · Diltiazem

    cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

    Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-0

Se muestran los 60 más recientes de 105.

¿Qué significan las clases de retiro?

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).

Fuentes

  1. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
  2. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
  3. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026

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