CoQ10 for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling all strengths of CoQ10 for Injection nationwide. The manufacturer cannot assure the product meets sterility requirements required for injectable medications.
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 injectable drug recall due to inability to assure product sterility. Although no illnesses or injuries have been reported, injectable products without guaranteed sterility pose inherent risk of serious infection, meeting the 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 CoQ10 for Injection distributed nationwide. The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements for injectable pharmaceuticals.
Injectable products must be sterile to prevent infection when administered to patients. Lack of assurance of sterility means the manufacturer cannot guarantee the product is free from harmful microorganisms. This applies to all lots currently within their expiration dates.
Patients who have received or are considering this medication should consult their healthcare provider immediately. Healthcare providers should review patient records for administration of this product and contact affected patients if necessary. Do not use any remaining product; follow your healthcare provider's instructions.
The recalled product
- Product
- CoQ10 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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