Fabrikant-profiel
Amneal Pharmaceuticals NY LLC
Farmaceutisch bedrijf4 producten gevolgd
4
producten gevolgd
82.223
totaal meldingen
16
recalls geregistreerd
64,7%
ernstig algeheel
Producten
4 van 4 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| — | 43.079 | probleem met hechting van hulpmiddel | 15 | |
| 2008 | 22.647 | verhoogd aantal bloedplaatjes | 1 | |
| — | 9.456 | methaemoglobinemie | 0 | |
| 1997 | 7.041 | migraine | 0 |
Recall-geschiedenis · 12 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 16 mei 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 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 11 mei 2019 | I | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. | Novartis Pharmaceuticals Corp. |
| 7 sep 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 sep 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 mei 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 mei 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. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Amneal Pharmaceuticals NY 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.