Recalls / Class II
Class IID-0142-2018
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
- Affected lot / code info
- 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
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-0142-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.