Recall D-0296-2025
Description: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Recall D-0296-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0296-2025 |
| Event ID | 96446 |
| Distribution | U.S. Nationwide |
| Quantity | 2,310 cassettes |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20250402 |
| Recall Initiation Date | 20250306 |
| Report Date | 20250402 |
| Classification Date | 20250325 |
| Address | 1075 W Park One Dr Ste 100N/A Sugar Land, TX 77478-2576 United States |
| Recalling Firm | QuVa Pharma, Inc. |
| Initial Notification | Letter |
| Similar To |