FDA-Drug2024-04-10Class II
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
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Hazard
Lack of Assurance of Sterility: Firm did not perform process validation.
Sold states
MO
Affected count
11,798 syringes
Manufactured in
1015 Bowles Ave, Fenton, MO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2024Don't want to check this manually?
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