B5 Dexpanthenol for Injection Recalled Due to Sterility Assurance Concerns
GenoGenix LLC is recalling B5 Dexpanthenol for Injection due to lack of assurance of sterility. The recall affects all lots within expiry 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: This is an FDA Class II drug recall for lack of sterility assurance in an injectable medication. While Class II recalls can be serious, this specific recall reports no illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
GenoGenix LLC is recalling B5 Dexpanthenol for Injection, all strengths and presentations, due to lack of assurance of sterility. The recalled product was distributed nationwide.
The recall involves all lots of B5 Dexpanthenol for Injection remaining within their expiration dates. For injectable medications, the inability to assure sterility is a critical manufacturing deficiency that must be addressed.
Healthcare providers and patients with this product should contact their healthcare provider about what to do. Additional information about the recall is available from GenoGenix LLC.
The recalled product
- Product
- B5 Dexpanthenol 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
- lack-of-sterility
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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