FDA Drug Class II — Moderate

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Hazard

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Products

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Brand
Advanced Nutriceuticals, LLC
UPC
Lot #1110202006, exp 12/10/2020

Units Affected

1 vial