Cardinal Health 107, LLC

Compañía farmacéutica6 productos registrados

productos registrados

384.679

notificaciones totales

220

retiradas registradas

75,0%

graves en total

Productos

mostrando 6 de 6

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
losartan —	1995	206.980	Enfermedad renal crónica	100
losartan potassium —	1995	87.627	Enfermedad renal crónica	100
doxazosin —	1990	35.427	hiperpotasemia	16
haloperidol lactate —	1967	24.303	síndrome neuroléptico maligno	1
rifaximin —	2004	20.331	aumento de amoniaco	2
dronedarone —	2009	10.011	Fibrilación auricular	1

Historial de retiradas · 50 registradas

Fecha	Clase	Motivo	Empresa
21 ene 2026	III	Tablets/Capsules Imprinted with Wrong ID	Unichem Pharmaceuticals USA Inc.
23 dic 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
23 dic 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
30 abr 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
30 abr 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
26 jun 2023	II	Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.	Strides Pharma Inc.
23 mar 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
23 mar 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
20 mar 2023	II	cGMP Deviations	RemedyRepack Inc.
16 mar 2023	II	CGMP Deviations	Northwind Pharmaceuticals LLC
7 feb 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 feb 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 feb 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 feb 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
6 jun 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6 jun 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6 jun 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
18 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
18 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
18 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
11 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .	Direct Rx
11 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .	Direct Rx
5 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Direct Rx
4 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	RemedyRepack Inc.
3 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Preferred Pharmaceuticals, Inc.
2 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
2 may 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
15 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
12 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Preferred Pharmaceuticals, Inc.
6 abr 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
31 mar 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31 mar 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31 mar 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
6 ago 2020	II	Failed Tablet/Capsule Specification; complaint of bulging tablet	Hetero Labs Limited (Unit V)
3 abr 2020	II	CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.	Golden State Medical Supply Inc.
26 mar 2020	II	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level	Avet Pharmaceuticals, Inc.
26 mar 2020	II	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level	Avet Pharmaceuticals, Inc.
25 mar 2020	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Teva Pharmaceuticals USA
25 mar 2020	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Teva Pharmaceuticals USA
25 mar 2020	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Teva Pharmaceuticals USA
19 sept 2019	II	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.	Torrent Pharma Inc.
20 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc
14 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Golden State Medical Supply Inc.
14 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Golden State Medical Supply Inc.
14 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Golden State Medical Supply Inc.
14 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Golden State Medical Supply Inc.
6 jun 2019	II	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Teva Pharmaceuticals USA

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

Estado de registro

Algunos productos de Cardinal Health 107, LLC 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.