Recall D-0064-2023
Description: PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Recall D-0064-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0064-2023 |
| Event ID | 91132 |
| Distribution | Nationwide in the USA |
| Quantity | 34,020 vials |
| Recall Reason | CGMP Deviations: Potential for cross contamination due to product carry over. |
| Drug Classification | Class II |
| Drug Code Info | 20221123 |
| Recall Initiation Date | 20221110 |
| Report Date | 20221123 |
| Classification Date | 20221117 |
| Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
| Recalling Firm | Nephron Sterile Compounding Center LLC |
| Initial Notification | Letter |
| Similar To |