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FDARecalled Apr 10, 2024 · #D-0436-2024

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 Facilit...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: Firm did not perform process validation. Classification: Class II Distribution: MO

Product details

Product
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
Type
Drugs
Manufacturer
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Model numbers
20231031-0C91D9
UPCs