Perfil del fabricante
AbbVie Inc.
Compañía farmacéutica8 productos registrados
8
productos registrados
283.974
notificaciones totales
9
retiradas registradas
59,1%
graves en total
Productos
mostrando 8 de 8
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 2019 | 76.996 | Operación de columna | 0 | |
| 2019 | 76.587 | Psoriasis | 0 | |
| 2016 | 59.616 | Leucemia mieloide aguda recurrente | 0 | |
| 1996 | 43.540 | Insuficiencia pancreática | 8 | |
| — | 10.868 | Hepatitis C | 0 | |
| 2021 | 6135 | Migraña | 0 | |
| — | 5942 | Absceso en el sitio de infusión | 0 | |
| 2018 | 4290 | Endometriosis | 1 |
Historial de retiradas · 17 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 18 may 2026 | III | Failed Stability Specifications | AbbVie Inc. |
| 16 sept 2024 | II | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. |
| 16 sept 2024 | II | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. |
| 17 oct 2023 | III | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose. | AbbVie Inc. |
| 23 jun 2023 | III | Failed Stability Specifications | Vivus, Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 22 ene 2018 | III | Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage. | AbbVie Inc. |
| 4 dic 2017 | II | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. | ALLERGAN |
| 8 sept 2017 | III | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | AbbVie Inc. |
| 13 ene 2017 | II | Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life | AbbVie Inc. |
| 24 mar 2016 | III | Failed Content Uniformity Specifications | AbbVie Inc. |
| 15 sept 2014 | II | Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. | AbbVie Inc |
| 2 jul 2013 | II | Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014; VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003726, EXP: 6/26/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 54092025290, Pedigree: W002790, EXP: 6/6/2014; CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: W002844, EXP: 6/7/2014; AT | Aidapak Services, LLC |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de AbbVie Inc. no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.