Drug 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
D-1078-2019
Product summary
- Event
- Event 82509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 250 mL bags
- Official record key
drug-enforcement:D-1078-2019
Official wording
Reason: Labeling: Label mix-up
Code information: Lot: 12112018@24 Exp. 01/25/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up