The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0181-2018·Announced 2018-01-17

KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Labeling Errors

KRS Global Biotechnology is recalling 596 vials of Hydroxocobalamin 1 mg/mL 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 due to labeling errors regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 596 vials of Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use. The product is prescription-only and was distributed nationwide in the USA, Bermuda, and New Zealand. The specific lot affected is 10162017@20 with a Beyond Use Date (BUD) of 2/13/2018.

The recall was initiated because of labeling errors where the Beyond Use Date (BUD) exceeded the expiration date of at least one ingredient used to make the final product. This resulted in incorrect or missing lot and/or expiration date information on the packaging.

Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Hydroxocobalamin 1 mg/mL 30 mL 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 Medication
Hazard
Affected units
596

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: 10162017@20 BUD: 2/13/2018

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 →

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