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Manufacturer profile

AbbVie Inc.

Pharmaceutical company8 products tracked
8
products tracked
283,974
total reports
9
recalls on record
59.1%
serious overall
Products
showing 8 of 8
ProductApprovedReports ↓Top signalRecalls
201976,996Spinal operation0
201976,587Psoriasis0
201659,616Acute myeloid leukaemia recurrent0
199643,540Pancreatic failure8
—10,868Hepatitis c0
20216,135Migraine0
—5,942Infusion site abscess0
20184,290Endometriosis1
Recall history · 17 on record
DateClassReasonFirm
May 18, 2026IIIFailed Stability SpecificationsAbbVie Inc.
Sep 16, 2024IILack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.AbbVie Inc.
Sep 16, 2024IILack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.AbbVie Inc.
Oct 17, 2023IIILabeling: 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.
Jun 23, 2023IIIFailed Stability SpecificationsVivus, Inc.
Mar 15, 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
Mar 15, 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
Jan 22, 2018IIIDefective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.AbbVie Inc.
Dec 4, 2017IISubpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.ALLERGAN
Sep 8, 2017IIITemperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.AbbVie Inc.
Jan 13, 2017IIFailed 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-lifeAbbVie Inc.
Mar 24, 2016IIIFailed Content Uniformity SpecificationsAbbVie Inc.
Sep 15, 2014IIPresence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.AbbVie Inc
Jul 2, 2013IILabeling: 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; amLODAidapak Services, LLC
Jul 2, 2013IILabeling: 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
Jul 2, 2013IILabeling: 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
Jul 2, 2013IILabeling: 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; ATAidapak Services, LLC

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from AbbVie Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.