FDA recall D-1237-2022

TMC Acquisition LLC dba Tailor Made Compounding · Class II · drug

Product

Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide USA and Puerto Rico

Key facts

Status
Ongoing
Initiation date
2022-03-07
Report date
2022-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nicholasville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1237-2022