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 |
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