FDAFDA · Food and drugs·Recall number D-0142-2018
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
Published January 3, 2018 · Recall initiated: August 10, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Distributor
- SSM Health entities in the state of MO only
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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