Par Pharmaceutical, Inc.
Overview
Par Pharmaceutical, Inc. is a subsidiary of Endo International plc, specializing in the development, manufacturing, and marketing of generic and specialty pharmaceutical products. The company focuses on delivering high-quality, cost-effective medications to improve patient health.
Therapeutic areas
API / Drug Master Files
Par Pharmaceutical, Inc. holds 0 active (2 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.
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SPRING VALLEY, NEW YORK.Inactive1985-08-08
- FACILITIES AND CONTROLSInactive1979-02-09
FDA compliance signals
17 FDA enforcement records linked to this company.
- recall — Class II2020-09-02
Failed Impurity /Degradation Specifications
- recall — Class II2020-04-08
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
- recall — Class III2020-03-25
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
- recall — Class III2020-02-19
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
- recall — Class I2019-05-15
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
- recall — Class III2018-09-19
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
- recall — Class II2016-12-07
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
- recall — Class III2016-11-09
Subpotent Drug; Ethinyl Estradiol
- recall — Class III2016-11-09
Subpotent Drug; Ethinyl Estradiol
- recall — Class III2016-11-09
Subpotent Drug; Ethinyl Estradiol
- recall — Class III2016-11-09
Subpotent Drug; Ethinyl Estradiol
- recall — Class III2016-11-09
Subpotent Drug; Ethinyl Estradiol
- recall — Class III2016-06-22
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
- recall — Class III2015-11-25
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- recall — Class III2015-11-25
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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