Injectable drug Tri-Immune recalled over sterility assurance issues
GenoGenix LLC is recalling all lots of Tri-Immune for Injection due to lack of assurance of sterility. The injectable medication is being recalled 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: This is an FDA Class II recall of an injectable medication. Although no illnesses or injuries have been reported, lack of sterility assurance in injectable products poses a risk of infection, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GenoGenix LLC is recalling Tri-Immune for Injection in all strengths and presentations due to a lack of assurance of sterility. The recall affects an estimated 166 units distributed nationwide in the United States.
Tri-Immune for Injection is an injectable medication that must be manufactured and distributed as a sterile product. The manufacturer has determined that it cannot provide assurance that all units meet sterility standards.
The recall applies to all affected lots currently within their expiration dates. Patients or healthcare providers who have this product should consult a physician. Anyone who received this injection should monitor for symptoms of infection and seek immediate medical attention if signs of infection develop.
The recalled product
- Product
- Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
- 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)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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