CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood,
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Summary
The FDA issued a Class II for CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 I by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado). Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0475-2025
Action Date
2025-07-02
Status
Ongoing
Category
drug
Product Description
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lot/Code Info: Lot#: H261968, Exp 12/23/2025; H261358, Exp 5/13/2025
Quantity Affected: 60 syringes
Reason for Recall
Lack of Assurance of Sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-21
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 57 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) has 14 FDA actions in our database, including 14 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) have FDA actions?
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) has 14 FDA actions in our database, including 14 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0475-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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