SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug;
Recalled January 3, 2018 · FDA recall D-0138-2018 · 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 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
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 →