FDA recall D-1231-2022
TMC Acquisition LLC dba Tailor Made Compounding · Class II · drug
Product
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 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-1231-2022