# FDA recall D-0435-2024

> **SSM Health Care St. Louis DBA SSM St. Clare Health Center** · Class II · drug recall initiated 2024-02-29.

## Product

Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394.  NDC: 60652-0104-1

## Reason for recall

Lack of Assurance of Sterility: Firm did not perform process validation.

## Distribution

MO

## Key facts

- **Recall number:** D-0435-2024
- **Recalling firm:** SSM Health Care St. Louis DBA SSM St. Clare Health Center
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-29
- **Report date:** 2024-04-10

- **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-0435-2024

## Citation

> AI Analytics. FDA recall D-0435-2024. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-0435-2024. Source: US FDA. Licensed CC0.

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