KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 1,009 vials of Hydroxocobalamin 0.5 mg/mL because the Beyond Use Date exceeds the expiration date of at least one ingredient.
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 a labeling error (incorrect or missing lot/exp date) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 1,009 vials of Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial. The product is prescription-only and was distributed nationwide in the USA, Bermuda, and New Zealand. The specific lot affected is 1010202017@9 with a Beyond Use Date (BUD) of 2/7/2018.
The recall was initiated due to 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.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, 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
- 1,009
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: 10102017@9 BUD: 2/7/2018
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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