Cardinal Health 107, LLC

Société pharmaceutique6 produits suivis

produits suivis

384 679

total des notifications

220

rappels enregistrés

75,0%

graves au total

Produits

affichage de 6 sur 6

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
losartan —	1995	206 980	Maladie rénale chronique	100
losartan potassium —	1995	87 627	Maladie rénale chronique	100
doxazosin —	1990	35 427	hyperkaliémie	16
haloperidol lactate —	1967	24 303	syndrome malin des neuroleptiques	1
rifaximin —	2004	20 331	augmentation de l'ammoniac	2
dronedarone —	2009	10 011	Fibrillation auriculaire	1

Historique des rappels · 50 enregistrés

Date	Classe	Motif	Fabricant
21 janv. 2026	III	Tablets/Capsules Imprinted with Wrong ID	Unichem Pharmaceuticals USA Inc.
23 déc. 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
23 déc. 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
30 avr. 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
30 avr. 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
26 juin 2023	II	Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.	Strides Pharma Inc.
23 mars 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
23 mars 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
20 mars 2023	II	cGMP Deviations	RemedyRepack Inc.
16 mars 2023	II	CGMP Deviations	Northwind Pharmaceuticals LLC
7 févr. 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 févr. 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 févr. 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
7 févr. 2023	II	CGMP Deviations: recalling drug products following an FDA inspection.	Accord Healthcare, Inc.
6 juin 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6 juin 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6 juin 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
18 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
18 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
18 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Strides Pharma Inc.
11 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .	Direct Rx
11 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .	Direct Rx
5 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Direct Rx
4 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	RemedyRepack Inc.
3 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Preferred Pharmaceuticals, Inc.
2 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
2 mai 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
15 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
12 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Preferred Pharmaceuticals, Inc.
6 avr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
31 mars 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31 mars 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31 mars 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
6 août 2020	II	Failed Tablet/Capsule Specification; complaint of bulging tablet	Hetero Labs Limited (Unit V)
3 avr. 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 mars 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 mars 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 mars 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 mars 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 mars 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 juin 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 juin 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 juin 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 juin 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 juin 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 juin 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

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Cardinal Health 107, LLC ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.