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Recall Observatory FDA recall evidence

Drug product

Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

D-0160-2020

October 10, 2019

Class II

Product summary

Firm
Innoveix Pharmaceuticals Inc
Event
Event 84006
Status
Terminated
Classification
Class II
Quantity
290 vials
Official record key
drug-enforcement:D-0160-2020

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lots: INX 50 Exp. 5/1/20

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility