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
Recalled April 10, 2024 · FDA recall D-0435-2024 · SSM Health Care St. Louis
Hazard
Lack of Assurance of Sterility: Firm did not perform process validation. · FDA Class II
Units
11,798 syringes
Sold at
MO
Description
Lack of Assurance of Sterility: Firm did not perform process validation.
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
Manufacturer(s)
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →