Drug product
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
D-0159-2020
Product summary
- Event
- Event 84006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1747 vials
- Official record key
drug-enforcement:D-0159-2020
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lots: SER 925 Exp. 11/4/19; SER 930 Exp. 11/18/19; SER 935 Exp. 2/21/20; SER 400 Exp. 4/1/20; SER 405 Exp. 5/11/20; SER 410 Exp. 7/15/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility