Recall D-0435-2024
Description: Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
Recall D-0435-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0435-2024 |
| Event ID | 94198 |
| Distribution | MO |
| Quantity | 11,798 syringes |
| Recall Reason | Lack of Assurance of Sterility: Firm did not perform process validation. |
| Drug Classification | Class II |
| Drug Code Info | 20240410 |
| Recall Initiation Date | 20240229 |
| Report Date | 20240410 |
| Classification Date | 20240404 |
| Address | 1015 Bowles Ave Fenton, MO 63026-2394 United States |
| Recalling Firm | SSM Health Care St. Louis DBA SSM St. Clare Health Center |
| Initial Notification | Letter |
| Similar To |