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Recall Observatory FDA recall evidence

Drug product

LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

D-0476-2025

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
64 syringes
Official record key
drug-enforcement:D-0476-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: H277639, Exp 6/25/2025

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility