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Ascend Laboratories, LLC

Société pharmaceutique6 produits suivis
6
produits suivis
438 973
total des notifications
217
rappels enregistrés
77,1%
graves au total
Produits
affichage de 6 sur 6
ProduitApprouvéNotifications ↓Signal principalRappels
1986190 113Dépendance médicamenteuse100
1986119 783Dépendance médicamenteuse100
201986 447Lésion du système nerveux central1
201223 718Résistance à plusieurs médicaments7
—14 129Maladie rénale chronique9
20104 783Augmentation du score de l'échelle Expanded Disability Status Scale0
Historique des rappels · 50 enregistrés
DateClasseMotifFabricant
1 juin 2026IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisAscend Laboratories, LLC
5 mai 2026IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specificationsAscend Laboratories, LLC
27 avr. 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 août 2025IISuperpotent drugAscend Laboratories, LLC
21 juil. 2025IIFailed Dissolution Specifications: low dissolution resultsAscend Laboratories, LLC
9 juil. 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
9 juil. 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
23 mai 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 mai 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 févr. 2025IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.Safecor Health, LLC
6 févr. 2025IIFailed Dissolution SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC
7 janv. 2025IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
13 déc. 2024IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
12 déc. 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
12 déc. 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 mars 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 févr. 2024IICGMP Deviations: Out of specification for residual solvents.Micro Labs Limited
29 déc. 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 juil. 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
17 juil. 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
11 juil. 2023IIFailed Dissolution SpecificationsAscend Laboratories, LLC
17 mars 2023IIOut of specification (OOS) for Spectroscopic Identification test by IR.Ascend Laboratories, LLC
14 mars 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
14 mars 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
2 mars 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
2 mars 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
5 janv. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5 janv. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5 janv. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
28 déc. 2022IIPresence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.Ascend Laboratories, LLC
27 déc. 2022IILack of sterility assuranceSentara Infusion Services
17 juin 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 juin 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 janv. 2022IIFailed Dissolution Specifications.Ascend Laboratories, LLC
7 janv. 2022IIFailed Stability SpecificationsVistaPharm, Inc.
21 déc. 2021IIFailed impurities/degradation specificationsAscend Laboratories, LLC
3 déc. 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 déc. 2020IIILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 déc. 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 déc. 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
6 août 2020IILack of Assurance of SterilityFamily Pharmacy of Statesville

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Ascend Laboratories, LLC ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.