FDA recall D-1078-2019
KRS Global Biotechnology, Inc · Class II · 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
Reason for recall
Labeling: Label mix-up
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2019-01-16
- Report date
- 2019-04-10
- Termination date
- 2021-02-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Boca Raton, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1078-2019