SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug;
Recalled January 3, 2018 · FDA recall D-0136-2018 · SSM Health Care St. Louis
Hazard
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. · FDA Class II
Units
N/A
Sold at
SSM Health entities in the state of MO only
Description
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Product
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
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 →