Recalls / Class II
Class IID-1078-2019
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
- Affected lot / code info
- Lot: 12112018@24 Exp. 01/25/2019
Why it was recalled
Labeling: Label mix-up
Recalling firm
- Firm
- KRS Global Biotechnology, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, Florida 33487-3633
Distribution
- Quantity
- 190 250 mL bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-01-16
- FDA classified
- 2019-04-04
- Posted by FDA
- 2019-04-10
- Terminated
- 2021-02-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1078-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.