KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.
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 (label mix-up). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are typically scored as Moderate (2).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 433 bags of NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF). The product is a prescription-only intravenous (IV) bag with the NDC 3321674481. The specific lot affected is 12122018@7 with an expiration date of 02/10/2019.
The recall was initiated due to a labeling error, specifically a label mix-up. The agency classifies this recall as Class II. The product was distributed nationwide in the United States.
Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be quarantined and not used. Consumers should contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Hazard
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: 12122018@7 Exp. 02/10/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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