FDA recall D-0477-2025

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Class II · drug

Product

LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-05-21
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2025