Recall D-0395-2024
Description: fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
Recall D-0395-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0395-2024 |
Event ID | 93456 |
Distribution | Nationwide in the USA |
Quantity | 548 bags |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20240403 |
Recall Initiation Date | 20231109 |
Report Date | 20240403 |
Classification Date | 20240322 |
Address | 755 Rainbow Rd Ste B Windsor, CT 06095-1024 United States |
Recalling Firm | SCA Pharmaceuticals, LLC |
Initial Notification | Letter |
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