Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues
GenoGenix LLC is recalling all lots of Vitamin D3 for Injection due to lack of assurance of sterility. The affected injectables were 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 sterility assurance issue for injectable medication, which carries inherent risk of serious infection if contaminated, but no illnesses or injuries have been reported.
Plain-English summary
GenoGenix LLC is recalling all strengths and presentations of Vitamin D3 for Injection due to lack of assurance of sterility. A total of 339 units are affected.
The recalled product was distributed nationwide across the United States. All lot numbers that remain within their expiration dates are included in this recall.
Patients and healthcare providers who have obtained this product should discontinue use and consult with a healthcare provider about appropriate alternatives. Do not use this product if you have it in your possession.
The recalled product
- Product
- Vitamin D3 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 Medication
- Hazard
- sterility-assurance
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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