Recalls / Class II
Class IID-0136-2018
Product
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
- Affected lot / code info
- Lot: 170614-006, exp 9/12/2017
Why it was recalled
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.
Recalling firm
- Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1015 Bowles Ave, N/A, Fenton, Missouri 63026-2394
Distribution
- Quantity
- N/A
- Distribution pattern
- SSM Health entities in the state of MO only
Timeline
- Recall initiated
- 2017-08-10
- FDA classified
- 2017-12-28
- Posted by FDA
- 2018-01-03
- Terminated
- 2018-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0136-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.