Profil du fabricant
AbbVie Inc.
Société pharmaceutique8 produits suivis
8
produits suivis
283 974
total des notifications
9
rappels enregistrés
59,1%
graves au total
Produits
affichage de 8 sur 8
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 2019 | 76 996 | Opération de la colonne vertébrale | 0 | |
| 2019 | 76 587 | Psoriasis | 0 | |
| 2016 | 59 616 | Leucémie myéloïde aiguë récurrente | 0 | |
| 1996 | 43 540 | Insuffisance pancréatique | 8 | |
| — | 10 868 | Hépatite C | 0 | |
| 2021 | 6 135 | Migraine | 0 | |
| — | 5 942 | Abcès au site de perfusion | 0 | |
| 2018 | 4 290 | Endométriose | 1 |
Historique des rappels · 17 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 18 mai 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 juin 2023 | III | Failed Stability Specifications | Vivus, Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 22 janv. 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 déc. 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 janv. 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 mars 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 juil. 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 juil. 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 juil. 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 juil. 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 |
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 AbbVie Inc. 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.