Biotin for Injection Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling Biotin for Injection nationwide due to lack of assurance of sterility. The injectable product does not meet required sterility standards.
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 with lack of sterility assurance represents a risk-of-harm product where no illnesses have been reported, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of Biotin for Injection distributed nationwide. Approximately 296 units of the product are affected. All lots within their expiration dates are included in the recall.
The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements. Biotin for Injection is an injectable medication that must be sterile to prevent serious infections such as sepsis or other complications.
Healthcare providers and patients who have received or have in their possession the recalled Biotin for Injection should not use the product. Contact GenoGenix LLC or your healthcare provider with questions about obtaining a replacement or refund. Speak to a healthcare provider if you have already received an injection of the recalled product.
The recalled product
- Product
- Biotin 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 / Biotin
- 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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