Recall D-0020-2025
Description: NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Recall D-0020-2025 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0020-2025 |
Event ID | 95427 |
Distribution | Product was distributed to 125 direct accounts nationwide. |
Quantity | 733 bags |
Recall Reason | cGMP violations |
Drug Classification | Class II |
Drug Code Info | 20241030 |
Recall Initiation Date | 20240925 |
Report Date | 20241030 |
Classification Date | 20241021 |
Address | 20 Dan RdN/A Canton, MA 02021-2809 United States |
Recalling Firm | Fresenius Kabi Compounding, LLC |
Initial Notification | Letter |
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