# FDA recall D-0141-2018

> **SSM Health Care St. Louis DBA SSM St. Clare Health Center** · Class II · drug recall initiated 2017-08-10.

## 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

## Reason for recall

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.

## Distribution

SSM Health entities in the state of MO only

## Key facts

- **Recall number:** D-0141-2018
- **Recalling firm:** SSM Health Care St. Louis DBA SSM St. Clare Health Center
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-10
- **Report date:** 2018-01-03
- **Termination date:** 2018-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fenton, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2018

## Citation

> AI Analytics. FDA recall D-0141-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0141-2018. Source: US FDA. Licensed CC0.

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