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
Product summary
- 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
Lack of Sterility