HealthProves
Startseite/Hersteller/Ascend Laboratories, LLC
Herstellerprofil

Ascend Laboratories, LLC

Pharmaunternehmen6 erfasste Produkte
6
erfasste Produkte
438.973
Meldungen insgesamt
217
dokumentierte Rückrufe
77,1%
schwerwiegend insgesamt
Produkte
6 von 6 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
1986190.113Abhängigkeit von Medikamenten100
1986119.783Abhängigkeit von Medikamenten100
201986.447Läsion im zentralen Nervensystem1
201223.718Resistenz gegen mehrere Medikamente7
—14.129Chronische Nierenerkrankung9
20104.783Erhöhter EDSS-Score0
Rückrufhistorie · 50 dokumentiert
DatumKlasseGrundFirma
1. Juni 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. Apr. 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. Aug. 2025IISuperpotent drugAscend Laboratories, LLC
21. Juli 2025IIFailed Dissolution Specifications: low dissolution resultsAscend Laboratories, LLC
9. Juli 2025IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.Ascend Laboratories, LLC
9. Juli 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. 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. Jan. 2025IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
13. Dez. 2024IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
12. Dez. 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
12. Dez. 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
22. Okt. 2024IIFailed Impurities/Degradation SpecificationDr. Reddy's Laboratories, Inc.
3. Sept. 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
12. März 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. Dez. 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. Juli 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
17. Juli 2023IILack of assurance of sterility: Lack of validation data for sanitization cyclesCentral Admixture Pharmacy Services Inc
11. Juli 2023IIFailed Dissolution SpecificationsAscend Laboratories, LLC
17. März 2023IIOut of specification (OOS) for Spectroscopic Identification test by IR.Ascend Laboratories, LLC
14. März 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
14. März 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
2. März 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
2. März 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
5. Jan. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5. Jan. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
5. Jan. 2023IIFailed Dissolution SpecificationAscend Laboratories, LLC
28. Dez. 2022IIPresence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.Ascend Laboratories, LLC
27. Dez. 2022IILack of sterility assuranceSentara Infusion Services
17. Juni 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. Juni 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. Jan. 2022IIFailed Dissolution Specifications.Ascend Laboratories, LLC
7. Jan. 2022IIFailed Stability SpecificationsVistaPharm, Inc.
21. Dez. 2021IIFailed impurities/degradation specificationsAscend Laboratories, LLC
3. Dez. 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. Dez. 2020IIILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17. Dez. 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17. Dez. 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
6. Aug. 2020IILack of Assurance of SterilityFamily Pharmacy of Statesville

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Ascend Laboratories, LLC sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.