Alvogen, Inc.
Overview
Alvogen, Inc. is a global pharmaceutical company that specializes in the development, manufacturing, and marketing of generic, brand, and over-the-counter products. The company has a broad global footprint and focuses on delivering high-quality medications with a diverse portfolio across many therapeutic areas.
Therapeutic areas
API / Drug Master Files
Alvogen, Inc. holds 1 active (1 total) FDA Type II Drug Master File — 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.
- PYRIMETHAMINEActive2019-05-28
FDA compliance signals
25 FDA enforcement records linked to this company.
- recall — Class II2026-01-21
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
- recall — Class I2025-02-26
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
- recall — Class II2023-03-08
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- recall — Class II2021-07-14
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- 4832021-06-10
Failure to comply with REMS Implementation System
- 4832020-09-11
Failure to develop written procedures
- 4832020-09-11
Late submission of 15-day report
- 4832020-09-11
Interval
- recall — Class II2019-08-21
Failed dissolution specifications
- recall — Class II2019-08-21
Failed dissolution specifications
- recall — Class I2019-05-15
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class II2017-07-12
Lack of Assurance of Sterility
- recall — Class III2017-04-12
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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