Drug product
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
D-0692-2021
Product summary
- Event
- Event 88159
- Status
- Completed
- Classification
- Class II
- Quantity
- 728 vials
- Official record key
drug-enforcement:D-0692-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility