PlainRecalls
FDA Drug Moderate Class II Terminated

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

Reported: October 9, 2019 Initiated: September 12, 2019 #D-0082-2020

Product Description

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
2760 bags
Distribution
Nationwide
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217. Recalled by KRS Global Biotechnology, Inc. Units affected: 2760 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0082-2020.