Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Failed Impurities/Degradation Specifications
Failed Disintegration Specifications: above the time expected.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Subpotent Drug
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Presence of Foreign Substance
Failed PH Specifications
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Presence of Particulate Matter.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
cGMP deviations.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Out of specification for dissolution.
Presence of particulate matter - Glass like particles.
cGMP Deviations
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
