KRS Global Recalls NORepinephrine IV Bags Due to Label Mix-Up
KRS Global recalls NORepinephrine 16 mg IV bags with labeling mix-up. This affects specific lot numbers and may cause confusion in medical use. Contact for details.
Lower-risk recall
Labeling: Label mix-up
Contact the company
What happened, in plain English
KRS Global is recalling NORepinephrine 16 mg IV bags that have a labeling mix-up. This could lead to incorrect medication use in medical settings, so healthcare providers should verify the product. Read more at govinfonow.com/recall/39240-krs-global-recalls-norepinephrine-iv-bags-due-to-label-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/39240-krs-global-recalls-norepinephrine-iv-bags-due-to-label-mix · Updated October 5, 2026 · FDA enforcement record: FDA #D-1078-2019
Cite this page
“KRS Global Recalls NORepinephrine IV Bags Due to Label Mix-Up.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39240-krs-global-recalls-norepinephrine-iv-bags-due-to-label-mix. Based on FDA recall #D-1078-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1078-2019%22&limit=1).
Why it’s dangerous
The labeling mix-up means the product might be confused with another medication. This could lead to incorrect dosing or administration in medical settings, but it does not cause immediate harm.
Who’s affected
Healthcare providers using the recalled NORepinephrine IV bags for medical treatments. Patients receiving this medication under a doctor's supervision are not directly affected.
How to tell if you have this one
Check for the NDC code 3321678343 and lot number 12112018@24. The product was sold with an expiration date of 01/25/2019.
- Brand
KRS Global- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1078-2019 | NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343; Lot: 12112018@24 Exp. 01/25/2019 | 190 250 mL bags |
| D-1079-2019 | 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; Lot: 12122018@7 Exp. 02/10/2019 | 433 250 mL bags |
What to do — step by step
Check Product Label
Verify the NDC code and lot number on the IV bag to confirm it is not the recalled version.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous if used correctly?
No, the labeling mix-up does not make the product dangerous if used correctly. The risk is confusion in labeling.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1078-2019 (January 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1078-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.