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FDANovember 30, 2020drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

advanced nutriceuticalsadvanced

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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