KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 479 vials of Vitamin 9 Lyophilized Vial due to incorrect or missing lot and expiration dates.
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 2/5 (Moderate).
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 and involves minor labeling errors regarding expiration dates, which fits the Moderate severity criteria for low-risk contamination or labeling issues.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 479 vials of Vitamin 9 Lyophilized Vial, For IM Use, Rx Only. The recall is due to labeling issues where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected product is distributed nationwide in the USA, Bermuda, and New Zealand. The specific lot number is 07102017@4 with a Beyond Use Date of 1/6/2018.
Consumers and healthcare providers should stop using the affected product and contact KRS Global Biotechnology for further instructions.
The recalled product
- Product
- Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biological / Lyophilized
- Hazard
- Affected units
- 479
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: 07102017@4 BUD: 1/6/2018
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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