D-0435-2024Class II

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-04-10

Distribution

Firm state

Product quantity

11,798 syringes

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

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

Product 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

Code / lot 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.

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IArgon Medical Devices, Inc 2026-07-22Class IIOlympus Corporation of the Americas 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.