FDA recall D-0144-2021

Advanced Nutriceuticals, LLC · Class II · drug

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.

Distribution

CA, CO, FL, IN, KY, OH, TX

Key facts

Status
Ongoing
Initiation date
2020-11-30
Report date
2020-12-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0144-2021