SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded inj
Recalled January 3, 2018 · FDA recall D-0143-2018 · 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
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
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 →