Herstellerprofil
AbbVie Inc.
Pharmaunternehmen8 erfasste Produkte
8
erfasste Produkte
283.974
Meldungen insgesamt
9
dokumentierte Rückrufe
59,1%
schwerwiegend insgesamt
Produkte
8 von 8 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 2019 | 76.996 | Wirbelsäulenoperation | 0 | |
| 2019 | 76.587 | Schuppenflechte | 0 | |
| 2016 | 59.616 | Wiederkehrende akute myeloische Leukämie | 0 | |
| 1996 | 43.540 | Pankreasinsuffizienz | 8 | |
| — | 10.868 | Hepatitis C | 0 | |
| 2021 | 6.135 | Migräne | 0 | |
| — | 5.942 | Abszess an der Infusionsstelle | 0 | |
| 2018 | 4.290 | Endometriose | 1 |
Rückrufhistorie · 17 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 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. Okt. 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. Juni 2023 | III | Failed Stability Specifications | Vivus, Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 22. Jan. 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. Dez. 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. Jan. 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. März 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. Juli 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. Juli 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. Juli 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. Juli 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von AbbVie Inc. sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.