Class I - Dangerous
Failed Impurity /Degradation Specifications
Par Pharmaceutical
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class I - Dangerous
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
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.
Class I - Dangerous
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
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.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Class I - Dangerous
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.