Herstellerprofil
Amneal Pharmaceuticals NY LLC
Pharmaunternehmen4 erfasste Produkte
4
erfasste Produkte
82.223
Meldungen insgesamt
16
dokumentierte Rückrufe
64,7%
schwerwiegend insgesamt
Produkte
4 von 4 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| — | 43.079 | Problem mit Gerätehaftung | 15 | |
| 2008 | 22.647 | Erhöhte Blutplättchenzahl | 1 | |
| — | 9.456 | Methämoglobinämie | 0 | |
| 1997 | 7.041 | Migräne | 0 |
Rückrufhistorie · 12 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 16. Mai 2024 | III | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc |
| 21. Feb. 2023 | III | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. | Padagis US LLC |
| 16. Apr. 2021 | II | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 11. Mai 2019 | I | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. | Novartis Pharmaceuticals Corp. |
| 7. Sept. 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| 7. Sept. 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| 4. Mai 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| 4. Mai 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| 26. Feb. 2018 | II | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product. | Paddock Laboratories, LLC. |
| 27. Apr. 2017 | III | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Noven Pharmaceuticals, Inc. |
| 25. Feb. 2015 | II | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Noven Pharmaceuticals, Inc. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Amneal Pharmaceuticals NY 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.