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Ascend Laboratories, LLC

Farmaceutisch bedrijf6 producten gevolgd
6
producten gevolgd
438.973
totaal meldingen
217
recalls geregistreerd
77,1%
ernstig algeheel
Producten
6 van 6 getoond
ProductGoedgekeurdMeldingen ↓Top signaalRecalls
1986190.113medicijnverslaving100
1986119.783medicijnverslaving100
201986.447laesie centraal zenuwstelsel1
201223.718Resistentie tegen meerdere geneesmiddelen7
—14.129chronische nierziekte9
20104.783verhoogde score op de Expanded Disability Status Scale0
Recall-geschiedenis · 50 geregistreerd
DatumKlasseRedenBedrijf
1 jun 2026IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisAscend Laboratories, LLC
5 mei 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 sep 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sep 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sep 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
19 sep 2025IIFailed Dissolution SpecificationsAscend Laboratories, LLC
28 aug 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 mei 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 mei 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 dec 2024IIPresence of Foreign Tablets/CapsulesAmerisource Health Services LLC
12 dec 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
12 dec 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 sep 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
12 mrt 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 dec 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 mrt 2023IIOut of specification (OOS) for Spectroscopic Identification test by IR.Ascend Laboratories, LLC
14 mrt 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
14 mrt 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
2 mrt 2023IICGMP Deviations: Potential risk of Cross ContaminationBreckenridge Pharmaceutical, Inc
2 mrt 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 dec 2022IIPresence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.Ascend Laboratories, LLC
27 dec 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 jan 2022IIFailed Dissolution Specifications.Ascend Laboratories, LLC
7 jan 2022IIFailed Stability SpecificationsVistaPharm, Inc.
21 dec 2021IIFailed impurities/degradation specificationsAscend Laboratories, LLC
3 dec 2021IIILabeling: Missing LabelAkorn, Inc.
12 nov 2021IILack of Assurance of SterilitySterRx, LLC
17 sep 2021IIDefective container: Cracked vials leading to lack of sterility assuranceFresenius Kabi USA LLC
17 dec 2020IIILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 dec 2020IILack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unitSCA Pharmaceuticals
17 dec 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

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Registratiestatus

Sommige producten van Ascend Laboratories, LLC zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.