Recall D-0945-2023
Description: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Recall D-0945-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0945-2023 |
| Event ID | 92737 |
| Distribution | KY and NJ |
| Quantity | 183 bags |
| Recall Reason | cGMP deviations: due to shipment of rejected units. |
| Drug Classification | Class II |
| Drug Code Info | 20230802 |
| Recall Initiation Date | 20230720 |
| Report Date | 20230802 |
| Classification Date | 20230726 |
| Address | 755 Rainbow Rd Ste B Windsor, CT 06095-1024 United States |
| Recalling Firm | SCA Pharmaceuticals |
| Initial Notification | Letter |
| Similar To |