FDA recall D-0157-2020

Innoveix Pharmaceuticals Inc · Class II · drug

Product

Lyophilized Chorionic Gonadotropin 11,000 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-0157-2020