D-0486-2025 Class II Ongoing
FDA drug recall D-0486-2025 was initiated by Thrive Health And Wellness, LLC, Dba Thrive Health Solutions (Colorado) on May 21, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 242 syringes.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 2, 2025
- Initiation Date
- May 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 242 syringes
Product description
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
Reason for recall
Lack of Assurance of Sterility
Distribution pattern
USA Nationwide
Code information
Lot: C03125A
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0486-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026