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Recall Observatory FDA recall evidence

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

D-0477-2025

May 21, 2025

Class II

Product summary

Firm
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Event
Event 96742
Status
Ongoing
Classification
Class II
Quantity
102 syringes
Official record key
drug-enforcement:D-0477-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: H227226, Exp 12/24/2025; H360175, Exp 6/2/2025; H368308, Exp 6/2/2025; Lot S360175, Exp 6/2/2025

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility