Superpotent Drug: above specification for the assay.
Vintage Pharmaceuticals LLC
Failed Impurities/ Degradation Specifications
Failed Stability Specifications
Presence of Particulate Matter.
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Failed Dissolution Specifications
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Tablet Separation: Possibility of cracked or split coating on the tablets.
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.