FDA Recalls Nicotinamide Adenine Dinucleotide Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 2,535 vials of Nicotinamide Adenine Dinucleotide 500 mg because the Beyond Use Date exceeds the expiration date of at least one ingredient.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (incorrect or missing lot/exp date) where the BUD exceeds the ingredient expiration date, which fits the criteria for moderate severity involving minor labeling errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only. The product is manufactured by KRS Global Biotechnology, Inc. The recall involves 2,535 vials from Lot 06062017@3.
The reason for the recall is a labeling defect where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product. This is classified as an FDA Class II recall.
The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,535
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: 06062017@3 BUD: 12/3/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 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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