Profil du fabricant
American Health Packaging
Société pharmaceutique9 produits suivis
9
produits suivis
305 146
total des notifications
58
rappels enregistrés
81,2%
graves au total
Produits
affichage de 9 sur 9
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1968 | 88 112 | Colite ulcéreuse | 2 | |
| 1980 | 75 807 | Dyskinésie tardive | 12 | |
| 1995 | 38 413 | Hypoglycémie | 21 | |
| — | 31 032 | Rejet de greffe rénale | 3 | |
| 1965 | 20 833 | Complication de sédation | 0 | |
| — | 19 587 | produit rappelé | 0 | |
| 1998 | 15 829 | Mutation virale identifiée | 2 | |
| 2009 | 12 295 | Thrombose dans un dispositif | 3 | |
| 1978 | 3 238 | Hypernatrémie | 15 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 23 mai 2025 | II | Presence of foreign tablets/capsules. | Teva Pharmaceuticals USA, Inc |
| 5 mars 2025 | II | Failed Dissolution Specifications | Golden State Medical Supply Inc. |
| 25 févr. 2025 | II | Failed Dissolution Specifications - low dissolution results | MYLAN PHARMACEUTICALS INC |
| 3 sept. 2024 | II | Failed Dissolution Specifications | Ascend Laboratories, LLC |
| 18 janv. 2024 | III | Misprint on tablet | Dr. Reddy's Laboratories, Inc. |
| 18 janv. 2024 | III | Misprint on tablet | Dr. Reddy's Laboratories, Inc. |
| 6 avr. 2023 | II | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. |
| 23 mars 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 23 mars 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 20 mars 2023 | II | cGMP Deviations | RemedyRepack Inc. |
| 17 mars 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17 mars 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17 mars 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 16 mars 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 16 mars 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 13 mars 2023 | II | cGMP deviations | Direct Rx |
| 13 mars 2023 | II | cGMP deviations | Direct Rx |
| 13 mars 2023 | II | cGMP deviations | Direct Rx |
| 7 févr. 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 7 févr. 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 7 févr. 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 5 déc. 2022 | II | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | RemedyRepack Inc. |
| 23 nov. 2022 | II | Subpotent Drug | Heritage Pharmaceuticals Inc |
| 29 juin 2022 | II | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA |
| 3 mai 2022 | III | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time. | American Health Packaging |
| 12 avr. 2022 | III | Subpotent Drug: Out of specification for assay. | American Health Packaging |
| 22 févr. 2022 | II | Impurity failure at 0-time of the repackaged lot. | American Health Packaging |
| 20 déc. 2021 | II | Failed Dissolution Specifications | American Health Packaging |
| 17 sept. 2021 | II | Failed Dissolution Specifications: results were above specification. | American Health Packaging |
| 29 juil. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 12 mai 2021 | III | Failed Impurities/Degradation Specifications | American Health Packaging |
| 26 avr. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 févr. 2021 | II | Chemical contamination; Unknown brown residue adhering to the inside of one vial. | Teva Pharmaceuticals USA |
| 10 févr. 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 10 févr. 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 7 janv. 2021 | II | Failed Dissolution Specifications | American Health Packaging |
| 21 juil. 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21 juil. 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21 juil. 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 10 juin 2020 | III | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. | American Health Packaging |
| 19 mai 2020 | II | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). | American Health Packaging |
| 7 févr. 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging |
| 7 févr. 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging |
| 27 janv. 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA |
| 27 janv. 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA |
| 4 déc. 2019 | II | Failed Dissolution Specifications: Low out of specification results obtained during stability testing. | American Health Packaging |
| 20 nov. 2019 | II | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. | American Health Packaging |
| 1 nov. 2019 | II | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging |
| 18 oct. 2019 | II | Failed Dissolution Specification: Low out of specification dissolution results. | Mylan 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 American Health Packaging 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.