Cardinal Health 107, LLC

Pharmaunternehmen6 erfasste Produkte

erfasste Produkte

384.679

Meldungen insgesamt

220

dokumentierte Rückrufe

75,0%

schwerwiegend insgesamt

Produkte

6 von 6 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
losartan —	1995	206.980	Chronische Nierenerkrankung	100
losartan potassium —	1995	87.627	Chronische Nierenerkrankung	100
doxazosin —	1990	35.427	Hyperkaliämie	16
haloperidol lactate —	1967	24.303	Neuroleptisches malignes Syndrom	1
rifaximin —	2004	20.331	Erhöhtes Ammoniak	2
dronedarone —	2009	10.011	Vorhofflimmern	1

Rückrufhistorie · 50 dokumentiert

Datum	Klasse	Grund	Firma
21. Jan. 2026	III	Tablets/Capsules Imprinted with Wrong ID	Unichem Pharmaceuticals USA Inc.
23. Dez. 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
23. Dez. 2024	II	Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.	Viatris Inc
30. Apr. 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
30. Apr. 2024	II	Failed Impurities/Degradation Specifications	Viatris Inc
26. Juni 2023	II	Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.	Strides Pharma Inc.
23. März 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
23. März 2023	II	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Preferred Pharmaceuticals, Inc.
20. März 2023	II	cGMP Deviations	RemedyRepack Inc.
16. März 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. Juni 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6. Juni 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	PD-Rx Pharmaceuticals, Inc.
6. Juni 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. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
15. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Macleods Pharma Usa Inc
12. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Preferred Pharmaceuticals, Inc.
6. Apr. 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	RemedyRepack Inc.
31. März 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31. März 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
31. März 2022	II	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Lupin Pharmaceuticals Inc.
6. Aug. 2020	II	Failed Tablet/Capsule Specification; complaint of bulging tablet	Hetero Labs Limited (Unit V)
3. Apr. 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. März 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. März 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. März 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. März 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. März 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. Juni 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. Juni 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. Juni 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. Juni 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. Juni 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. Juni 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

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Cardinal Health 107, LLC sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.