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Ascend Laboratories, LLC

Compañía farmacéutica6 productos registrados
6
productos registrados
438.973
notificaciones totales
217
retiradas registradas
77,1%
graves en total
Productos
mostrando 6 de 6
ProductoAprobadoNotificaciones ↓Señal principalRetiradas
1986190.113Dependencia de fármaco100
1986119.783Dependencia de fármaco100
201986.447Lesión del sistema nervioso central1
201223.718Resistencia a múltiples fármacos7
—14.129Enfermedad renal crónica9
20104783Aumento de la puntuación en la Escala Expandida de Estado de Discapacidad0
Historial de retiradas · 50 registradas
FechaClaseMotivoEmpresa
1 jun 2026IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisAscend Laboratories, LLC
5 may 2026IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specificationsAscend Laboratories, LLC
27 abr 2026IIFailed Dissolution SpecificationsAscend Laboratories, LLC
26 nov 2025IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.Winder Laboratories, LLC
19 sept 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sept 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sept 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sept 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
28 ago 2025IISuperpotent drugAscend Laboratories, LLC
21 jul 2025IIFailed Dissolution Specifications: low dissolution resultsAscend Laboratories, LLC
9 jul 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
9 jul 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
23 may 2025IIFailed 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 2025IIFailed 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
17 feb 2025IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.Safecor Health, LLC
6 feb 2025IIFailed Dissolution SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC
7 ene 2025IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
13 dic 2024IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
12 dic 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
12 dic 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
22 oct 2024IIFailed Impurities/Degradation SpecificationDr. Reddy's Laboratories, Inc.
3 sept 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
12 mar 2024IIThe filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.Hikma Pharmaceuticals USA Inc.
12 feb 2024IICGMP Deviations: Out of specification for residual solvents.Micro Labs Limited
29 dic 2023IIPresence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.Ascend Laboratories, LLC
17 jul 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
17 jul 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
11 jul 2023IIFailed Dissolution SpecificationsAscend Laboratories, LLC
17 mar 2023IIOut of specification (OOS) for Spectroscopic Identification test by IR.Ascend Laboratories, LLC
14 mar 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
14 mar 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
2 mar 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
2 mar 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
5 ene 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5 ene 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5 ene 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
28 dic 2022IIPresence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.Ascend Laboratories, LLC
27 dic 2022IILack of sterility assuranceSentara Infusion Services
17 jun 2022ILabeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.Bryant Ranch Prepack, Inc.
17 jun 2022ILabeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.Bryant Ranch Prepack, Inc.
12 ene 2022IIFailed Dissolution Specifications.Ascend Laboratories, LLC
7 ene 2022IIFailed Stability SpecificationsVistaPharm, Inc.
21 dic 2021IIFailed impurities/degradation specificationsAscend Laboratories, LLC
3 dic 2021IIILabeling: Missing LabelAkorn, Inc.
12 nov 2021IILack of Assurance of SterilitySterRx, LLC
17 sept 2021IIDefective container: Cracked vials leading to lack of sterility assuranceFresenius Kabi USA LLC
17 dic 2020IIILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 dic 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 dic 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
6 ago 2020IILack of Assurance of SterilityFamily Pharmacy of Statesville

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Ascend Laboratories, LLC 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.