Allergan, Inc.
Overview
Allergan, Inc. is a leading global pharmaceutical company, primarily focused on developing and marketing a broad range of branded pharmaceutical, device, biologic, surgical, and regenerative medicine products for patients around the world. It is a subsidiary of AbbVie Inc.
Therapeutic areas
API / Drug Master Files
Allergan, Inc. holds 0 active (3 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.
- BOTOX (R) (BOTULINUM TOXIN TYPE A) PURIFIED NEUROTOXIN COMPLEXInactive2004-01-09
- MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN WACO, TEXAS.Inactive1994-09-16
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PUERTO RICO.Inactive1993-11-29
FDA compliance signals
9 FDA enforcement records linked to this company.
- recall — Class II2021-01-27
Labeling: Missing instructions for use insert
- recall — Class III2020-08-05
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- recall — Class III2020-08-05
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
- recall — Class II2019-01-16
GMP Deviations: A silicone particulate was noted in Ozurdex.
- recall — Class II2018-12-05
Failed Stability Specification: out of specification for iron content.
- recall — Class I2018-06-20
Contraceptive Tablets Out of Sequence.
- recall — Class II2018-03-07
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
- recall — Class III2018-02-21
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
- recall — Class II2018-01-17
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
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