Drug product
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
D-0435-2024
Product summary
- Event
- Event 94198
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,798 syringes
- Official record key
drug-enforcement:D-0435-2024
Official wording
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
Code information: Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.
Distribution pattern: MO
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility