SSM Health Care St. Louis DBA SSM St. Clare Health Center: Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug

Hazard

Lack of Assurance of Sterility: Firm did not perform process validation.

Details from the source

Reason for recall: Lack of Assurance of Sterility: Firm did not perform process validation. Distribution: MO Quantity: 11,798 syringes Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.