Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a sterility assurance failure. Lack of sterile assurance in injectable medications represents a serious risk of harm including infection, and the product is subject to regulatory classification as Class II, meeting the criteria for Severe.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL) pre-filled syringes, Lot C03125A, due to lack of assurance of sterility. A total of 242 syringes from this lot were distributed nationwide.
The lack of assured sterility means the product may not meet required safety and purity standards for injectable medications. Consumers who have received this product should contact their healthcare provider immediately for guidance. Healthcare providers and patients should not use or administer product from this lot.
Consumers with questions about this recall or who believe they have been affected should contact Thrive Health Solutions at 88 Inverness Circle East, Suite A-204, Englewood, Colorado 80112.
The recalled product
- 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
- Manufacturer
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: C03125A
Distribution
Distributed nationwide across the United States.
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