PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 10, 2019 Initiated: January 16, 2019 #D-1078-2019

Product Description

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

Reason for Recall

Labeling: Label mix-up

Details

Units Affected
190 250 mL bags
Distribution
Nationwide in the USA
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by KRS Global Biotechnology, Inc. Units affected: 190 250 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-1078-2019.