FDA recall D-1204-2022

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

Product

GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-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-1204-2022