Profil du fabricant
Amneal Pharmaceuticals LLC
Société pharmaceutique8 produits suivis
8
produits suivis
165 802
total des notifications
23
rappels enregistrés
86,6%
graves au total
Produits
affichage de 8 sur 8
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1990 | 54 798 | Colite ulcéreuse | 10 | |
| 2004 | 36 718 | Progression de la tumeur maligne | 1 | |
| 2004 | 36 708 | Progression de la tumeur maligne | 0 | |
| — | 12 505 | Dégénérescence maculaire | 4 | |
| 2005 | 11 390 | Augmentation de l'ADN de l'hépatite B | 6 | |
| 2008 | 10 727 | Rétention urinaire | 2 | |
| — | 1 713 | obstruction des voies aériennes supérieures | 0 | |
| 1984 | 1 243 | Complication de sédation | 0 |
Historique des rappels · 20 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 16 déc. 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 oct. 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 févr. 2024 | II | Failed Dissolution Specifications: Out of specification for dissolution. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 18 janv. 2024 | II | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 30 oct. 2020 | II | Failed Dissolution Specifications | AVKARE Inc. |
| 28 oct. 2020 | II | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 20 févr. 2020 | II | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA |
| 12 juin 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 20 juil. 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 déc. 2016 | II | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC |
| 2 déc. 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 juil. 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 juil. 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 juil. 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 juil. 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 |
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 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.