FDAFDA · Food and drugs·Recall number D-0136-2018
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
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: 170614-006, exp 9/12/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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