Ultra Burn for Injection Recalled for Sterility Assurance Failure
GenoGenix is recalling all lots of Ultra Burn for Injection due to lack of assurance of sterility. Patients using this product 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 FDA Class II recall addresses a manufacturing quality assurance failure in an injectable drug with no reported illnesses or injuries. Injectable products with unassured sterility present a significant 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 all strengths and presentations of Ultra Burn for Injection nationwide due to a lack of assurance of sterility.
The recall was issued because the manufacturer cannot assure that the injectable product meets sterility requirements. For injectable drugs, sterility is a critical quality attribute because any microbial contamination could pose a serious risk of infection to patients.
The recall affects all lots that remain within their expiration dates. Patients who have received or are currently using this product should contact their healthcare provider immediately for guidance. Healthcare providers should discontinue dispensing and administering the product and should notify patients who have already received it to discuss appropriate follow-up care.
The recalled product
- Product
- Ultra Burn 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 / Injection
- Hazard
- sterility-assurance-failure
- 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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
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