FDA recall D-1213-2022
TMC Acquisition LLC dba Tailor Made Compounding · Class II · drug
Product
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 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-1213-2022