NAD+ Injectable Solution Recalled for Lack of Sterility Assurance
GenoGenix LLC is recalling all NAD+ injectable solution vials due to lack of assurance of sterility. All affected lots within expiration remain available for return.
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 a Class II drug recall for an injectable product with a sterility assurance issue, posing a risk of infection. No illnesses or injuries have been reported in the source material, making the hazard theoretical. The score is High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GenoGenix LLC is recalling NAD+ (Nicotinamide adenine dinucleotide) injectable solution in all strengths and presentations (50 mg/mL and 100 mg/mL, 10 mL multi-dose vials) due to lack of assurance of sterility.
This recall affects all lots that remain within their expiration date. The product has been distributed nationwide in the United States.
Consumers who have received this product should discontinue use immediately and contact their healthcare provider. Healthcare providers and patients should return the product to GenoGenix LLC (2840 NW 2nd Ave Ste 204, Boca Raton, FL 33431-6692) for a refund or replacement.
The recalled product
- Product
- NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, 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 Solution
- Hazard
- lack-of-sterility-assurance
- contamination-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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