PlainRecalls
FDA Drug Moderate Class II Ongoing

AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

Reported: December 23, 2020 Initiated: November 30, 2020 #D-0131-2021

Product Description

AOD-9604, 1200 MCG/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.

Details

Units Affected
3 vials
Distribution
CA, CO, FL, IN, KY, OH, TX
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN. Recalled by Advanced Nutriceuticals, LLC. Units affected: 3 vials.
Why was this product recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0131-2021.