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American Health Packaging

Compañía farmacéutica9 productos registrados
9
productos registrados
305.146
notificaciones totales
58
retiradas registradas
81,2%
graves en total
Productos
mostrando 9 de 9
ProductoAprobadoNotificaciones ↓Señal principalRetiradas
196888.112Colitis ulcerosa2
198075.807Discinesia tardía12
199538.413Hipoglucemia21
—31.032Rechazo de trasplante de riñón3
196520.833Complicación de la sedación0
—19.587producto retirado0
199815.829Mutación viral identificada2
200912.295Trombosis en dispositivo3
19783238Hipernatremia15
Historial de retiradas · 50 registradas
FechaClaseMotivoEmpresa
23 may 2025IIPresence of foreign tablets/capsules.Teva Pharmaceuticals USA, Inc
5 mar 2025IIFailed Dissolution SpecificationsGolden State Medical Supply Inc.
25 feb 2025IIFailed Dissolution Specifications - low dissolution resultsMYLAN PHARMACEUTICALS INC
3 sept 2024IIFailed Dissolution SpecificationsAscend Laboratories, LLC
18 ene 2024IIIMisprint on tabletDr. Reddy's Laboratories, Inc.
18 ene 2024IIIMisprint on tabletDr. Reddy's Laboratories, Inc.
6 abr 2023IICGMP deviations.PD-Rx Pharmaceuticals, Inc.
23 mar 2023IIcGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.Preferred Pharmaceuticals, Inc.
23 mar 2023IIcGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.Preferred Pharmaceuticals, Inc.
20 mar 2023IIcGMP DeviationsRemedyRepack Inc.
17 mar 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
17 mar 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
17 mar 2023IICGMP Deviations: recalling drug products following an FDA inspection.Amerisource Health Services LLC
16 mar 2023IICGMP DeviationsNorthwind Pharmaceuticals LLC
16 mar 2023IICGMP DeviationsNorthwind Pharmaceuticals LLC
13 mar 2023IIcGMP deviationsDirect Rx
13 mar 2023IIcGMP deviationsDirect Rx
13 mar 2023IIcGMP deviationsDirect Rx
7 feb 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
7 feb 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
7 feb 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
5 dic 2022IISubpotent Drug: repackaged product was recalled by the manufacturer for subpotency.RemedyRepack Inc.
23 nov 2022IISubpotent DrugHeritage Pharmaceuticals Inc
29 jun 2022IICGMP DeviationsGlenmark Pharmaceuticals Inc., USA
3 may 2022IIIFailed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.American Health Packaging
12 abr 2022IIISubpotent Drug: Out of specification for assay.American Health Packaging
22 feb 2022IIImpurity failure at 0-time of the repackaged lot.American Health Packaging
20 dic 2021IIFailed Dissolution SpecificationsAmerican Health Packaging
17 sept 2021IIFailed Dissolution Specifications: results were above specification.American Health Packaging
29 jul 2021IILack of Assurance of SterilityTeva Pharmaceuticals USA
12 may 2021IIIFailed Impurities/Degradation SpecificationsAmerican Health Packaging
26 abr 2021IILack of Assurance of SterilityTeva Pharmaceuticals USA
15 mar 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
15 feb 2021IIChemical contamination; Unknown brown residue adhering to the inside of one vial.Teva Pharmaceuticals USA
10 feb 2021IILack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.Teva Pharmaceuticals USA
10 feb 2021IILack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.Teva Pharmaceuticals USA
7 ene 2021IIFailed Dissolution SpecificationsAmerican Health Packaging
21 jul 2020ISuperpotent DrugFerring Pharmaceuticals Inc
21 jul 2020ISuperpotent DrugFerring Pharmaceuticals Inc
21 jul 2020ISuperpotent DrugFerring Pharmaceuticals Inc
10 jun 2020IIILabeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.American Health Packaging
19 may 2020IIFailed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).American Health Packaging
7 feb 2020IIGMP Deviations: Product bottle may be absent of desiccant.American Health Packaging
7 feb 2020IIGMP Deviations: Product bottle may be absent of desiccant.American Health Packaging
27 ene 2020IIGMP Deviations: Product bottle may be absent of desiccant.Teva Pharmaceuticals USA
27 ene 2020IIGMP Deviations: Product bottle may be absent of desiccant.Teva Pharmaceuticals USA
4 dic 2019IIFailed Dissolution Specifications: Low out of specification results obtained during stability testing.American Health Packaging
20 nov 2019IICGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.American Health Packaging
1 nov 2019IICGMP Deviations: Presence of NDMA impurity detected in product.American Health Packaging
18 oct 2019IIFailed Dissolution Specification: Low out of specification dissolution results.Mylan Pharmaceuticals Inc.

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

Estado de registro

Algunos productos de American Health Packaging 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.