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Recall Observatory FDA recall evidence

Drug product

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

D-0693-2021

July 09, 2021

Class II

Product summary

Firm
Innoveix Pharmaceuticals Inc
Event
Event 88159
Status
Completed
Classification
Class II
Quantity
1,316 vials
Official record key
drug-enforcement:D-0693-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility