FDA recall D-0160-2020
Innoveix Pharmaceuticals Inc · Class II · drug
Product
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason for recall
Lack of Sterility Assurance.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-10
- Report date
- 2019-11-06
- Termination date
- 2022-01-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Addison, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2020