Fabrikant-profiel
Cardinal Health 107, LLC
Farmaceutisch bedrijf6 producten gevolgd
6
producten gevolgd
384.679
totaal meldingen
220
recalls geregistreerd
75,0%
ernstig algeheel
Producten
6 van 6 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1995 | 206.980 | chronische nierziekte | 100 | |
| 1995 | 87.627 | chronische nierziekte | 100 | |
| 1990 | 35.427 | hyperkaliëmie | 16 | |
| 1967 | 24.303 | neuroleptisch maligne syndroom | 1 | |
| 2004 | 20.331 | verhoogd ammoniak | 2 | |
| 2009 | 10.011 | atriumfibrilleren | 1 |
Recall-geschiedenis · 50 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 21 jan 2026 | III | Tablets/Capsules Imprinted with Wrong ID | Unichem Pharmaceuticals USA Inc. |
| 23 dec 2024 | II | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc |
| 23 dec 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 jun 2023 | II | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Strides Pharma Inc. |
| 23 mrt 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 23 mrt 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 20 mrt 2023 | II | cGMP Deviations | RemedyRepack Inc. |
| 16 mrt 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 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| 18 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| 18 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. |
| 11 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx |
| 11 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx |
| 5 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Direct Rx |
| 4 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | RemedyRepack Inc. |
| 3 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Preferred Pharmaceuticals, Inc. |
| 2 mei 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. |
| 2 mei 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 mrt 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. |
| 31 mrt 2022 | II | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. |
| 31 mrt 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 mrt 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 mrt 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 mrt 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 mrt 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 mrt 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 sep 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Cardinal Health 107, LLC zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.