Profil du fabricant
Amneal Pharmaceuticals NY LLC
Société pharmaceutique4 produits suivis
4
produits suivis
82 223
total des notifications
16
rappels enregistrés
64,7%
graves au total
Produits
affichage de 4 sur 4
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| — | 43 079 | problème d'adhérence du dispositif | 15 | |
| 2008 | 22 647 | Augmentation du nombre de plaquettes | 1 | |
| — | 9 456 | Méthémoglobinémie | 0 | |
| 1997 | 7 041 | Migraine | 0 |
Historique des rappels · 12 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 16 mai 2024 | III | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc |
| 21 févr. 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 avr. 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 mars 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 févr. 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 avr. 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 févr. 2015 | II | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Noven Pharmaceuticals, Inc. |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Amneal Pharmaceuticals NY LLC ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.