Recall D-1347-2022
Description: PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Recall D-1347-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1347-2022 |
| Event ID | 90718 |
| Distribution | Nationwide in the USA |
| Quantity | 33,870 vials |
| Recall Reason | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Recall Initiation Date | 20220810 |
| Report Date | 20220824 |
| Classification Date | 20220816 |
| Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
| Recalling Firm | Nephron Sterile Compounding Center LLC |
| Initial Notification | Letter |
| Similar To |