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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01

D-0142-2018

August 10, 2017

Class II

Product summary

Firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Event
Event 78678
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0142-2018

Official wording

Reason: 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.

Code information: Lot, exp: 170614-007, 9/12/2017; 170628-001, 9/26/2017; 170703-017, 10/1/2017; 170706-009, 10/4/2017; 170719-007, 10/17/2017

Distribution pattern: SSM Health entities in the state of MO only

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial growth
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility