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
Product summary
- 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
Microbial growth
-
Sterility assurance
Lack of sterility