Phenylephrine HCl recalled over sterility concerns

Recall date

February 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0435-2024

FDA classification

Class II

Brand / firm

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

Sold / distributed

MO

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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