Perfil del fabricante
Alembic Pharmaceuticals Limited
Compañía farmacéutica8 productos registrados
8
productos registrados
283.448
notificaciones totales
19
retiradas registradas
66,7%
graves en total
Productos
mostrando 8 de 8
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 2010 | 78.131 | Anemia hemorrágica | 5 | |
| — | 69.814 | Reacción a fármacos con eosinofilia y síntomas sistémicos | 0 | |
| — | 59.849 | Infección de las vías respiratorias inferiores | 0 | |
| 2009 | 41.144 | hemangioma renal | 0 | |
| 1987 | 13.393 | Degeneración macular | 13 | |
| 2011 | 9105 | sueños anormales | 0 | |
| — | 8068 | aumento de la presión intraocular | 0 | |
| 1996 | 3944 | dolor en el lugar de infusión | 1 |
Historial de retiradas · 19 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 17 feb 2026 | II | Defective container; inadequately sealed blister packaging. | The Harvard Drug Group LLC |
| 16 dic 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 oct 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 25 jul 2025 | II | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Alembic Pharmaceuticals Limited |
| 9 may 2025 | II | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule | Alembic Pharmaceuticals Limited |
| 12 dic 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 12 dic 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 30 ago 2024 | II | Subpotent Drug | Glenmark Pharmaceuticals Inc., USA |
| 14 mar 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 14 mar 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 10 jun 2020 | II | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. | Alembic Pharmaceuticals Limited |
| 18 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 13 ago 2015 | II | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. |
| 13 ago 2015 | II | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. |
| 14 nov 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| 5 nov 2012 | II | Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product | Boehringer Ingelheim Roxane Inc |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Alembic Pharmaceuticals Limited no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.