Tirzepatide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling 216 syringes of Tirzepatide/Cyanocobalamin Injectable (lot C03065F) because the manufacturer cannot assure the products are sterile. Patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of an injectable product where sterility assurance is lacking. Although no illnesses or injuries have been reported in the source text, the product poses a risk of harm due to the potential for microbial contamination in injectables administered directly into the body.
Plain-English summary
Thrive Health and Wellness, LLC (operating as Thrive Health Solutions) is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL in pre-filled syringes due to lack of assurance of sterility. The recall affects lot C03065F, representing 216 syringes that have been distributed nationwide in the United States.
The issue is that the manufacturer cannot assure that the product meets sterility requirements. For injectable medications that are administered directly into the body, sterility is a critical quality attribute.
Patients who received or possess syringes from lot C03065F should contact their healthcare provider. Consumers with questions about the recall can contact Thrive Health Solutions at 88 Inverness Circle E, Suite A-204, Englewood, CO 80112.
The recalled product
- Product
- Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, 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 / Parenteral
- Hazard
- sterility-assurance
- infection-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: C03065F
Distribution
Distributed nationwide across the United States.
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