PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 10, 2019 Initiated: January 16, 2019 #D-1079-2019

Product Description

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

Reason for Recall

Labeling: Label mix-up

Details

Units Affected
433 250 mL bags
Distribution
Nationwide in the USA
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by KRS Global Biotechnology, Inc. Units affected: 433 250 mL bags.
Why was this product recalled?
Labeling: Label mix-up
Which agency issued this recall?
This recall was issued by the FDA Drug on April 10, 2019. Severity: Moderate. Recall number: D-1079-2019.