Recalls / Class II
Class IID-0486-2025
Product
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Affected lot / code info
- Lot: C03125A
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 88 Inverness Cir E Unit A204, Englewood, Colorado 80112-5521
Distribution
- Quantity
- 242 syringes
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-05-21
- FDA classified
- 2025-06-20
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0486-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.