NAD+ Injectable Solution Recalled Due to Lack of Sterility Assurance
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving a sterile injectable drug product. Loss of sterility assurance in an injectable carries significant risk of serious infection or other adverse health consequences, meeting the Severe (score 4) threshold for Class II with risk of serious harm.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling NAD+ (Nicotinamide adenine dinucleotide) 100mg/mL pre-filled syringes due to a lack of assurance of sterility. The affected product is distributed nationwide and includes Lot GA37484.
Lack of sterility assurance means the manufacturer cannot guarantee that the injectable product is free from microorganisms that could cause infection or other adverse effects if administered.
Consumers who have received this product should consult their healthcare provider about potential risks and any symptoms they may experience. Healthcare providers and patients should stop using the product and report any adverse events to the FDA.
The recalled product
- Product
- Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Affected units
- 16
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)
- Lot: GA37484
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) 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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