Fabrikant-profiel
AbbVie Inc.
Farmaceutisch bedrijf8 producten gevolgd
8
producten gevolgd
283.974
totaal meldingen
9
recalls geregistreerd
59,1%
ernstig algeheel
Producten
8 van 8 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 2019 | 76.996 | rugoperatie | 0 | |
| 2019 | 76.587 | psoriasis | 0 | |
| 2016 | 59.616 | Terugkerende acute myeloïde leukemie | 0 | |
| 1996 | 43.540 | pancreasfalen | 8 | |
| — | 10.868 | Hepatitis C | 0 | |
| 2021 | 6.135 | migraine | 0 | |
| — | 5.942 | abces op infusieplaats | 0 | |
| 2018 | 4.290 | Endometriose | 1 |
Recall-geschiedenis · 17 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 18 mei 2026 | III | Failed Stability Specifications | AbbVie Inc. |
| 16 sep 2024 | II | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. |
| 16 sep 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 jun 2023 | III | Failed Stability Specifications | Vivus, Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 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 dec 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 sep 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 mrt 2016 | III | Failed Content Uniformity Specifications | AbbVie Inc. |
| 15 sep 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van AbbVie Inc. zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.