Skip to content
Recall Observatory FDA recall evidence

Drug product

Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01

D-0141-2018

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-0141-2018

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: 170705-002, 10/03/2017

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