FDA recall D-0435-2024

SSM Health Care St. Louis DBA SSM St. Clare Health Center · Class II · 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

Reason for recall

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

Distribution

MO

Key facts

Status
Ongoing
Initiation date
2024-02-29
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2024