Impax Laboratories, LLC
Overview
Impax Laboratories, LLC is a pharmaceutical company based in the United States that develops, manufactures, and markets bioequivalent and brand-name pharmaceuticals. It is a subsidiary of Amneal Pharmaceuticals LLC following their merger. The company focuses on providing therapies for central nervous system disorders and other conditions.
Therapeutic areas
FDA compliance signals
6 FDA enforcement records linked to this company.
- recall — Class I2016-12-28
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
- recall — Class II2016-04-27
Failed Impurities/Degradation Specifications
- recall — Class II2016-04-27
Failed Impurities/Degradation Specifications
- recall — Class III2016-04-20
Labeling: Incorrect or Missing Lot and/or Exp. Date
- recall — Class III2016-04-20
Labeling: Incorrect or Missing Lot and/or Exp. Date
- warning_letter2011-05-31
FDA Warning Letter (drug product)
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