NAD+ injection recalled after elevated endotoxin levels found in one lot
GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
NAD+ (Nicotinamide adenine dinucleotide) for Injection, at 100 mg/mL and 200 mg/mL in 10 mL multi-dose amber vials, from GenoGenix, LLC of Boca Raton, Florida, is being recalled for microbial contamination of sterile products, specifically elevated endotoxin levels.
The recall covers lot GG121624-023 within expiry, distributed nationwide in the United States. The FDA has classified the recall as Class I.
Unlike the firm's other actions, which cite a loss of sterility assurance, this record states that contamination was found in the product.
Healthcare providers and patients holding the affected lot should stop using it immediately and contact the firm or their prescriber.
The recalled product
- Product
- NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- Manufacturer
- GenoGenix LLC
- Category
- Drug — Injectable
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 (2)
- Lot#: GG121624-023
- within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 57 recalled by GenoGenix LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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