Tesamorelin Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling Tesamorelin for Injection nationwide due to lack of assurance that sterile manufacturing standards are met. 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: FDA Class II recall of injectable medication for lack of manufacturing sterility assurance. No illnesses or injuries have been reported. The theoretical risk to patient safety of non-sterile injectable medication justifies a High classification, but absence of reported harm prevents a higher score.
Plain-English summary
GenoGenix LLC is recalling Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vials (Lot GG020425-004, within expiry) distributed nationwide.
The recall is issued because the manufacturer cannot assure that the product meets sterility requirements. Tesamorelin is an injectable medication; injectable drugs must be completely sterile to be safe.
If you have received medication from the recalled lot, stop use immediately and contact your healthcare provider. Do not resume use of the recalled product.
The recalled product
- Product
- Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- Hazard
- sterility
- 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#: GG020425-004 within expiry.
Distribution
Distributed nationwide across the United States.
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