D-0485-2025 Class II Ongoing

Recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) — Englewood, CO

FDA drug recall D-0485-2025 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: 216 syringes.

Recall Details

Product Type
Drugs
Report Date
July 2, 2025
Initiation Date
May 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
216 syringes

Product Description

Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, 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: C03065F