Medications & Supplements/Prescription Drugs

KRS Global Biotechnology, Inc: Norepinephrine IV Bags Recalled Due to Labeling Mix-Up

Agency Publication Date: April 4, 2019

Summary

KRS Global Biotechnology, Inc. is recalling 623 units of Norepinephrine IV bags, including Norepinephrine 16 mg in Sodium Chloride and Norepinephrine 4 mg in Dextrose, because of a label mix-up. This error means the contents of the IV bag may not match what is stated on the label, which can lead to patients receiving the wrong medication or the wrong dosage during critical care. Consumers and healthcare providers should check their inventory immediately for the affected lots and contact their healthcare provider or pharmacist for guidance.

Risk

A label mix-up can cause a patient to receive a different concentration of medication than intended, potentially leading to serious health complications like dangerously high or low blood pressure or improper heart rate management.

What You Should Do

Identify if you have the affected products by checking for these specific details: Norepinephrine 16 mg added to 0.9% Sodium Chloride (250 mL IV bag) with Lot 12112018@24 or 12112018 (Exp. 01/25/2019) and NDC 3321678343.
Identify if you have the affected Norepinephrine 4 mg added to 5% Dextrose (250 mL IV bag) with Lot 12122018@7 or 12122018 (Exp. 02/10/2019) and NDC 3321674481.
If you are a healthcare provider or patient in possession of these lots, stop using them immediately and set them aside to ensure they are not administered.
Contact your healthcare provider or pharmacist for guidance regarding these products and return any unused IV bags to the place of purchase for a refund.
Contact KRS Global Biotechnology, Inc. at their facility located at 791 Park of Commerce Blvd Ste 600, Boca Raton, Florida for further instructions on returning the product.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Product return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL (250 mL IV bag)

Model:

NDC 3321678343

Recall #: D-1078-2019

Lot Numbers:

12112018@24 (Exp. 01/25/2019)

12112018

Date Ranges: 01/25/2019

Product: NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL (250 mL IV bag)

Model:

NDC 3321674481

Recall #: D-1079-2019

Lot Numbers:

12122018@7 (Exp. 02/10/2019)

12122018

Date Ranges: 02/10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82509

Status: Resolved

Manufacturer: KRS Global Biotechnology, Inc

Sold By: hospitals; clinics

Manufactured In: United States

Units Affected: 2 products (190 250 mL bags; 433 250 mL bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected products by checking for these specific details: Norepinephrine 16 mg added to 0.9% Sodium Chloride (250 mL IV bag) with Lot 12112018@24 or 12112018 (Exp. 01/25/2019) and NDC 3321678343.

Identify if you have the affected Norepinephrine 4 mg added to 5% Dextrose (250 mL IV bag) with Lot 12122018@7 or 12122018 (Exp. 02/10/2019) and NDC 3321674481.

If you are a healthcare provider or patient in possession of these lots, stop using them immediately and set them aside to ensure they are not administered.

Contact your healthcare provider or pharmacist for guidance regarding these products and return any unused IV bags to the place of purchase for a refund.

Contact KRS Global Biotechnology, Inc. at their facility located at 791 Park of Commerce Blvd Ste 600, Boca Raton, Florida for further instructions on returning the product.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL (250 mL IV bag)

Model:

NDC 3321678343

Recall #: D-1078-2019

Lot Numbers:

12112018@24 (Exp. 01/25/2019)

12112018

Date Ranges: 01/25/2019

Product: NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL (250 mL IV bag)

Model:

NDC 3321674481

Recall #: D-1079-2019

Lot Numbers:

12122018@7 (Exp. 02/10/2019)

12122018

Date Ranges: 02/10/2019