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FDAAugust 10, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

ssm health care st louis dba ssm st clare health centerssmssm health

UPCs

88883427201

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear