GenoGenix Low Solubility Peptide Reconstitution Solution Lacks Sterility Assurance
GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection due to lack of assurance of sterility. The drug 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 without reported hospitalization or injury. The product is a risk-of-harm injectable medication where sterility failure could lead to infection, though no illnesses have been reported.
Plain-English summary
GenoGenix, LLC is recalling all lots of Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, distributed nationwide. The product is also labeled as manufactured for CELIA Health.
The recall is due to a lack of assurance of sterility. The company has determined that the product may not meet required sterility standards, which is a requirement for injectable medications.
Healthcare providers and patients should stop using the affected product immediately. If you have received this product, consult your healthcare provider about alternative treatments. Return the product to the pharmacy or manufacturer.
The recalled product
- Product
- Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable / Sterility
- Hazard
- sterility-failure
- 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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