Class II

Drug Recall: 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 F

SSM Health Care St. Louis DBA SSM St. Clare Health Center · February 29, 2024

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

Distribution

MO

States Affected

MO

Quantity Affected

11,798 syringes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0435-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.