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Recall Observatory FDA recall evidence

Drug product

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

D-1079-2019

January 16, 2019

Class II

Product summary

Firm
KRS Global Biotechnology, Inc
Event
Event 82509
Status
Terminated
Classification
Class II
Quantity
433 250 mL bags
Official record key
drug-enforcement:D-1079-2019

Official wording

Reason: Labeling: Label mix-up

Code information: Lot: 12122018@7 Exp. 02/10/2019

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label mix-up