Perfil del fabricante
A-S Medication Solutions
Compañía farmacéutica56 productos registrados
56
productos registrados
3.447.028
notificaciones totales
425
retiradas registradas
65,4%
graves en total
Productos
mostrando 56 de 56
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1972 | 491.157 | Lupus eritematoso sistémico | 11 | |
| 2000 | 308.680 | Palpitaciones | 100 | |
| — | 195.145 | Enfermedad renal crónica | 1 | |
| 2012 | 171.338 | Asma | 14 | |
| 1987 | 162.981 | Sinovitis | 12 | |
| 1979 | 137.410 | hiperpotasemia | 11 | |
| 2003 | 130.496 | Resistencia a múltiples fármacos | 18 | |
| 1998 | 129.432 | Artropatía psoriásica | 4 | |
| 1963 | 119.417 | Abuso de drogas | 13 | |
| 2012 | 118.894 | trastorno obstructivo de las vías respiratorias | 14 | |
| 2006 | 114.158 | trastorno obstructivo de las vías respiratorias | 2 | |
| 1974 | 99.955 | Enfermedad renal terminal | 20 | |
| 2019 | 98.103 | Hipertensión arterial pulmonar | 0 | |
| — | 95.176 | trastorno obstructivo de las vías respiratorias | 1 | |
| 2014 | 86.770 | Dosis insuficiente accidental | 3 | |
| 2015 | 77.542 | Desmineralización ósea | 3 | |
| 1986 | 66.038 | Epilepsia | 12 | |
| 2000 | 64.485 | Disminución de la glucosa en sangre | 5 | |
| 1982 | 63.743 | Infección por Clostridium difficile | 15 | |
| 1997 | 60.586 | cáncer de mama metastásico | 2 | |
| — | 59.089 | trastorno obstructivo de las vías respiratorias | 0 | |
| 2014 | 56.693 | cetoacidosis diabética | 1 | |
| 2015 | 41.643 | Desmineralización ósea | 0 | |
| 1984 | 39.971 | Alcoholismo | 17 | |
| 2005 | 38.856 | Aumento de la glucosa en sangre | 1 | |
| — | 35.132 | Desmineralización ósea | 0 | |
| 2001 | 34.581 | Enfermedad renal crónica | 11 | |
| 2013 | 30.943 | Infección del pie diabético | 1 | |
| — | 26.702 | Colestasis | 5 | |
| 2002 | 26.564 | Blefaroespasmo | 19 | |
| 2000 | 21.326 | Problema del mecanismo de administración del producto | 9 | |
| 1971 | 21.106 | Anemia nefrogénica | 24 | |
| 2012 | 20.686 | lesión dental | 0 | |
| 2001 | 19.663 | Sibilancias | 38 | |
| 2001 | 19.655 | Sibilancias | 0 | |
| 1980 | 18.541 | Anticuerpo anti-péptido citrulinado cíclico positivo | 13 | |
| — | 17.624 | Disminución de la densidad ósea | 0 | |
| 1977 | 16.938 | dolor en el lugar de infusión | 0 | |
| 1981 | 15.321 | Intento de suicidio | 0 | |
| — | 10.359 | Palpitaciones | 0 | |
| 2000 | 10.154 | Problema del mecanismo de administración del producto | 4 | |
| 1984 | 9868 | insatisfacción del paciente con el tratamiento | 1 | |
| 1976 | 9839 | Molestia nasal | 7 | |
| 2000 | 9134 | Ningún evento adverso | 0 | |
| 1982 | 8566 | Sopor | 0 | |
| 1996 | 5914 | Enfermedad renal crónica | 2 | |
| 1967 | 4388 | Flatulencia vaginal | 0 | |
| 1970 | 3461 | Erupción maculopapular | 3 | |
| 2018 | 3424 | Potasio en sangre anormal | 0 | |
| — | 3384 | Hidradenitis | 5 | |
| 1987 | 3377 | Linfedema | 0 | |
| 1999 | 3293 | Asma | 0 | |
| — | 2865 | metrorragia | 0 | |
| — | 2734 | Problema con el sistema de administración del dispositivo | 3 | |
| 2020 | 1984 | Irritación en el lugar de infusión | 0 | |
| — | 1744 | Desmineralización ósea | 0 |
Historial de retiradas · 50 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 28 may 2026 | II | CGMP Deviations | Ajanta Pharma USA Inc |
| 30 abr 2026 | II | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. | Safecor Health, LLC |
| 20 abr 2026 | II | Chemical contamination; presence of lead and lithium above specification | Acella Pharmaceuticals, LLC |
| 26 feb 2026 | II | Subpotent Drug | MACLEODS PHARMA USA, INC |
| 31 dic 2025 | II | Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. | Alvogen, Inc |
| 18 dic 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| 13 oct 2025 | II | Subpotent drug; Clavulanate Potassium component | Teva Pharmaceuticals USA, Inc |
| 15 sept 2025 | II | Failed Dissolution Specifications. | Amerisource Health Services LLC |
| 5 ago 2025 | II | Presence of foreign substance: identified as aluminum. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 29 jul 2025 | II | Subpotent drug | Pfizer |
| 20 jun 2025 | II | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. |
| 20 jun 2025 | II | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. |
| 20 jun 2025 | II | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. |
| 20 jun 2025 | II | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. |
| 20 jun 2025 | II | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. |
| 28 may 2025 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 23 may 2025 | II | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC |
| 23 may 2025 | II | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC |
| 13 may 2025 | II | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules | AvKARE |
| 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 |
| 10 abr 2025 | II | Subpotent | ACCORD HEALTHCARE, INC. |
| 10 abr 2025 | II | Subpotent | ACCORD HEALTHCARE, INC. |
| 13 mar 2025 | I | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. | Dr. Reddy's Laboratories, Inc. |
| 13 mar 2025 | II | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA |
| 13 mar 2025 | II | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA |
| 7 mar 2025 | II | Super-Potent Drug: Out of specification potency results were obtained. | Mylan Institutional, Inc. |
| 25 feb 2025 | II | Presence of Foreign Tablets/Capsules. | A-S Medication Solutions LLC |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 29 ene 2025 | II | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA |
| 20 dic 2024 | II | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. | Lupin Pharmaceuticals Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 19 nov 2024 | II | Subpotent and Superpotent Drug | Mylan Institutional, Inc. |
| 18 nov 2024 | II | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc |
| 18 nov 2024 | II | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris 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 A-S Medication Solutions 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.