Tirzepatide Injectable Solution Recalled for Lack of Sterility Assurance
GenoGenix has recalled Tirzepatide 60mg/10mL injectable vials nationwide due to lack of assurance of sterility. The affected lots are GG012925-005 and GG021125-003.
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 an FDA Class II recall. Although no illnesses or injuries have been reported, lack of sterility assurance in injectable medications represents a significant risk of infection and contamination. Per the rubric, when the hazard is theoretical and no illnesses have been reported, the maximum score is 3 (High).
Plain-English summary
GenoGenix LLC is recalling Tirzepatide 60mg/10mL for Injection in 10mL vial lyophilized presentations nationwide. The recall is due to lack of assurance of sterility, meaning the manufacturer cannot confirm that the product meets required sterility standards for injectable medications.
The affected lots are GG012925-005 and GG021125-003 (within expiry). The product was distributed nationwide under the GenoGenix label and also labeled for Extension Health and Synergy Wellness. Patients who have received doses from these lots should contact their healthcare provider immediately to discuss potential risks and recommended action. Healthcare providers and patients should discontinue use of the affected lots.
The recalled product
- Product
- Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- 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 (3)
- Lots GG012925-005
- GG021125-003
- within expiry.
Distribution
Distributed nationwide across the United States.
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