Presence of Particulate Matter.
PAR Sterile Products
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.