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FDARecalled Apr 10, 2024 · #D-0435-2024

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 Outsourcin...

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
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
Type
Drugs
Manufacturer
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Model numbers
UPCs