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Recall Observatory FDA recall evidence

Drug product

Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

D-0157-2020

October 10, 2019

Class II

Product summary

Firm
Innoveix Pharmaceuticals Inc
Event
Event 84006
Status
Terminated
Classification
Class II
Quantity
3905 vials
Official record key
drug-enforcement:D-0157-2020

Official wording

Reason: Lack of Sterility Assurance.

Code information: Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility