Fabrikant-profiel
Amneal Pharmaceuticals LLC
Farmaceutisch bedrijf8 producten gevolgd
8
producten gevolgd
165.802
totaal meldingen
23
recalls geregistreerd
86,6%
ernstig algeheel
Producten
8 van 8 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1990 | 54.798 | Colitis ulcerosa | 10 | |
| 2004 | 36.718 | progressie van kwaadaardige tumor | 1 | |
| 2004 | 36.708 | progressie van kwaadaardige tumor | 0 | |
| — | 12.505 | Maculadegeneratie | 4 | |
| 2005 | 11.390 | verhoogd hepatitis B DNA | 6 | |
| 2008 | 10.727 | Urine-retentie | 2 | |
| — | 1.713 | obstructie bovenste luchtwegen | 0 | |
| 1984 | 1.243 | complicatie van sedatie | 0 |
Recall-geschiedenis · 20 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 16 dec 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 okt 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 24 sep 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 24 sep 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 4 sep 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| 4 sep 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| 5 feb 2024 | II | Failed Dissolution Specifications: Out of specification for dissolution. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 18 jan 2024 | II | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 30 okt 2020 | II | Failed Dissolution Specifications | AVKARE Inc. |
| 28 okt 2020 | II | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 20 feb 2020 | II | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 20 jul 2017 | II | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. | Hetero USA Inc |
| 12 dec 2016 | II | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC |
| 2 dec 2016 | III | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules | Shire PLC |
| 20 mei 2014 | II | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. | Cambrex Charles City Inc |
| 2 jul 2013 | II | Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014. | Aidapak Services, LLC |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Amneal Pharmaceuticals 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.