Tirzepatide/Cyanocobalamin Injectable recalled over sterility concerns
- Recall date
- May 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, S…
- Recall number
- D-0485-2025
- FDA classification
- Class II
- Brand / firm
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Sold / distributed
- USA Nationwide
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
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