Semaglutide for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling specific lots of Semaglutide for Injection due to inability to assure product sterility. The product was distributed nationwide.
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: FDA Class II recall involving an injectable medication with unassured sterility. No illnesses or injuries are reported. Per the rubric, this is a high-risk contamination scenario with no reported harm, warranting a High severity score.
Plain-English summary
GenoGenix LLC is recalling Semaglutide for Injection, 20 mg and 20 mg/mL in 10 mL multi-dose vials, including product labeled for Synergy Wellness. The recall is due to lack of assurance of sterility, meaning the manufacturer cannot confirm that the injectable medication is free from microorganisms and contamination.
The recall affects lots GG021125-001 and GG031125-017, which were distributed nationwide across the United States.
Patients currently using this medication and healthcare providers who have dispensed these lots should discontinue use immediately and contact their healthcare provider to discuss alternative treatment options.
The recalled product
- Product
- Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable Medication
- 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)
- Lot#: GG021125-001
- GG031125-017
- within expiry.
Distribution
Distributed nationwide across the United States.
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