Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0205-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors

KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B 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 lot and expiration dates, which fits the criteria for a moderate severity recall.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only. The recall was initiated because the product has incorrect or missing lot and/or expiration dates. Specifically, the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.

The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. The recall covers specific lots with Beyond Use Dates ranging from November 19, 2017, to April 11, 2018.

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: Vitamin 10 B 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 — Injectable Vitamin
Hazard: mis-labeling
Affected units: 5,786

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 (12)

Lots
05232017@13 BUD: 11/19/2017
05262017@2 BUD: 11/22/2017
06022017@1 BUD: 11/29/2017
06092017@1 BUD: 12/6/2017
06162017@10 BUD: 12/13/2017
08142017@10 BUD: 2/10/2018
08252017@1 BUD: 2/21/2018
09222017@1 BUD: 3/21/2018
09292017@1 BUD: 3/28/2018
10062017@1 BUD: 4/4/2018
10132017@2 BUD: 4/11/2018

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.

See all 47 products in this recall →

Same manufacturer · KRS Global Biotechnology, Inc

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