The Recall Desk

FDA (Drugs) recall action 82509

KRS Global Biotechnology, Inc recalled 2 products on 2019-04-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-04-10
Critical
0
Units
—

Why these products were recalled

Labeling: Label mix-up

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2019-04-10

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-04-10

    KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error

    KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.

    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
    Category
    Distribution
    0 states