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Recall Observatory FDA recall evidence

Drug product

Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

D-0480-2025

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
164 syringes
Official record key
drug-enforcement:D-0480-2025

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: C03035J, Exp 7/3/2025, H202959, exp 7/6/2025; AB20N110720 , exp 7/7/2025 ; AB60N1121, exp 7/7/2025; PRX022225-1 , exp 8/24/2025 ; U122024 , exp 10/26/2025

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility