Product: Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: 20201130
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated