Herstellerprofil
Amneal Pharmaceuticals LLC
Pharmaunternehmen8 erfasste Produkte
8
erfasste Produkte
165.802
Meldungen insgesamt
23
dokumentierte Rückrufe
86,6%
schwerwiegend insgesamt
Produkte
8 von 8 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1990 | 54.798 | Colitis ulcerosa | 10 | |
| 2004 | 36.718 | Fortschreiten bösartiger Neubildungen | 1 | |
| 2004 | 36.708 | Fortschreiten bösartiger Neubildungen | 0 | |
| — | 12.505 | Makuladegeneration | 4 | |
| 2005 | 11.390 | Erhöhte Hepatitis-B-DNA | 6 | |
| 2008 | 10.727 | Harnverhalt | 2 | |
| — | 1.713 | Obstruktion der oberen Atemwege | 0 | |
| 1984 | 1.243 | Komplikation durch Sedierung | 0 |
Rückrufhistorie · 20 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 16. Dez. 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. Sept. 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 24. Sept. 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 4. Sept. 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| 4. Sept. 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. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 20. Juli 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. Dez. 2016 | II | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC |
| 2. Dez. 2016 | III | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules | Shire PLC |
| 20. Mai 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. Juli 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. Juli 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. Juli 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. Juli 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Amneal Pharmaceuticals 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.