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Recall Observatory FDA recall evidence

Drug product

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

D-0144-2021

November 30, 2020

Class II

Product summary

Firm
Advanced Nutriceuticals, LLC
Event
Event 86799
Status
Ongoing
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-0144-2021

Official wording

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

Code information: Lot #1110202006, exp 12/10/2020

Distribution pattern: CA, CO, FL, IN, KY, OH, TX

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility