Recall D-0358-2023
Description: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
Recall D-0358-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0358-2023 |
| Event ID | 91749 |
| Distribution | Nationwide in the USA |
| Quantity | 270,291 bottles |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Recall Initiation Date | 20230222 |
| Report Date | 20230308 |
| Classification Date | 20230227 |
| Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
| Recalling Firm | Nephron Sterile Compounding Center LLC |
| Initial Notification | Letter |
| Similar To |