Abbvie Inc.
Overview
AbbVie Inc. is a global, research-based biopharmaceutical company that develops and markets therapies for serious health challenges. Known for its innovative approach, AbbVie focuses on areas including immunology, oncology, virology, and neuroscience.
Therapeutic areas
API / Drug Master Files
Abbvie Inc. holds 7 active (15 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ERYTHROMYCIN BASEActive2015-11-10
- PARICALCITOL DRUG SUBSTANCEActive2010-11-30
- CYCLOSPORINE USPActive1998-09-01
- ERYTHROMYCIN ETHYLSUCCINATEActive1998-09-01
- ERYTHROMYCIN STEARATEActive1998-09-01
- ERYTHROMYCIN BASEActive1998-04-30
- BUTORPHANOL TARTRATEActive1990-12-20
- NIACIN CORE TABLET INTERMEDIATEInactive2008-10-31
- CHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATEInactive2007-11-13
- CHOLINE FENOFIBRATE DRUG SUBSTANCEInactive2007-11-13
- 5-DESOSAMINYL-6-0-METHYL ERYTHRONOLIDEInactive1999-12-22
- ERYTHROMYCIN BASEInactive1998-09-01
- CLINDAMYCIN PHOSPHATEInactive1998-09-01
- CLORAZEPATE DIPOTASSIUM (TRANXENE)Inactive1982-05-07
- PRAMOXINE HCLInactive1982-04-30
FDA compliance signals
20 FDA enforcement records linked to this company.
- recall — Class III2026-06-03
Failed Stability Specifications
- recall — Class II2024-10-02
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- recall — Class II2024-10-02
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- 4832024-04-18
Investigations of discrepancies, failures
- 4832024-04-18
Scientifically sound laboratory controls
- recall — Class III2023-11-15
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.
- 4832018-07-02
Late submission of 15-day report
- recall — Class III2018-02-07
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- recall — Class III2017-11-01
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- recall — Class III2017-11-01
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- recall — Class II2017-03-08
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
- recall — Class III2016-04-27
Failed Content Uniformity Specifications
- 4832015-08-06
Procedures to be written and followed
- recall — Class II2014-10-08
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
- recall — Class II2014-05-07
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
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