Drug product
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
D-0158-2020
Product summary
- Event
- Event 84006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 413 vials
- Official record key
drug-enforcement:D-0158-2020
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility