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Recall Observatory FDA recall evidence

Drug 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

D-0143-2018

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-0143-2018

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: 170619-011, 9/17/2017; 170707-007, 10/5/2017; 170713-009, 10/11/2017

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