KRS Global Biotechnology Recalls IV Nicotinamide Adenine Dinucleotide Vials
KRS Global Biotechnology is recalling 4,390 vials of IV Nicotinamide Adenine Dinucleotide due to a lack of assurance of sterility.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 4,390 vials of Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial. The product is prescription-only and was distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The affected product is identified by NDC 3321678103. The recall includes all lots remaining within their expiry dates. No specific lot numbers are listed in the source text.
Healthcare providers and patients should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Infusion
- Affected units
- 4,390
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc 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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