FDA-Drug2024-04-10Class II
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
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
140 vials
Manufactured in
1015 Bowles Ave, Fenton, MO, United States
Products
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2024Don't want to check this manually?
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