FDA recall D-0693-2021

Innoveix Pharmaceuticals Inc · Class II · drug

Product

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status: Completed
Initiation date: 2021-07-09
Report date: 2021-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Addison, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0693-2021