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Bryant Ranch Prepack

Compañía farmacéutica88 productos registrados
88
productos registrados
4.705.846
notificaciones totales
788
retiradas registradas
68,5%
graves en total
Productos
mostrando 88 de 88
ProductoAprobadoNotificacionesSeñal principalRetiradas
Historial de retiradas · 50 registradas
FechaClaseMotivoEmpresa
2 jun 2026IIIPresence of foreign substanceANI Pharmaceuticals, Inc.
29 may 2026IIFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.Golden State Medical Supply Inc.
27 may 2026IIFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.Lannett Company Inc.
29 abr 2026IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitZydus Pharmaceuticals (USA) Inc
29 abr 2026IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitZydus Pharmaceuticals (USA) Inc
9 abr 2026IIFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.The Harvard Drug Group LLC
20 mar 2026IICGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.Leading Pharma, LLC
10 ene 2026IIPresence of Foreign SubstanceGraviti Pharmaceuticals Private Limited
26 nov 2025IIIFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.SUN PHARMACEUTICAL INDUSTRIES INC
18 nov 2025IIICross Contamination with Other ProductsGlenmark Pharmaceuticals Inc., USA
20 oct 2025IIFailed Dissolution SpecificationsGolden State Medical Supply Inc.
10 oct 2025IIFailed Dissolution SpecificationsLannett Company Inc.
10 oct 2025IIFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .The Harvard Drug Group LLC
10 oct 2025IIFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .The Harvard Drug Group 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
3 sept 2025IIFailed Impurities/Degradation SpecificationsGlenmark Pharmaceuticals Inc., USA
19 jun 2025IIDefective container; blister packaging inadequately sealed.The Harvard Drug Group LLC
19 jun 2025IIDefective container; blister packaging inadequately sealed.The Harvard Drug Group LLC
27 may 2025IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Torrent Pharma Inc.
27 may 2025IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.Torrent Pharma Inc.
22 abr 2025IICGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.RemedyRePack Inc.
18 abr 2025IIcGMP DeviationsPreferred Pharmaceuticals, Inc.
24 mar 2025IICGMP DeviationsRemedyRepack Inc.
17 mar 2025IIFailed dissolution specifications: lower than specificationsBIOCON PHARMA INC
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
13 mar 2025IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
4 mar 2025IIICross ContaminationSUN PHARMACEUTICAL INDUSTRIES INC
4 mar 2025IIICross ContaminationSUN PHARMACEUTICAL INDUSTRIES INC
17 feb 2025IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.Safecor Health, LLC
27 dic 2024IIPresence of Particulate Matter: A market complaint was received of a glass piece in the vial.Eugia US LLC
17 dic 2024IIFailed Dissolution Specifications:Amerisource Health Services LLC
6 dic 2024IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.Aurobindo Pharma USA Inc
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
1 nov 2024IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Glenmark Pharmaceuticals Inc., USA
31 oct 2024IIDefective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).Noven Pharmaceuticals Inc
24 sept 2024IIPresence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.Nivagen Pharmaceuticals Inc
31 jul 2024IIPresence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin TabletsGranules Pharmaceuticals Inc.
26 jul 2024IIPresence of Particulate Matter: Complaint received of a glass particle in the vial.Eugia US LLC

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

Estado de registro

Algunos productos de Bryant Ranch Prepack 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.