FDA recall D-1196-2022
TMC Acquisition LLC dba Tailor Made Compounding · Class II · drug
Product
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, 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-1196-2022