Phenylephrine HCl — Class II drug recall D-0435-2024
Ongoing recall by SSM Health Care St. Louis DBA SSM St. Clare Health Center, reported 2024-04-10, distributed in MO. Lack of Assurance of Sterility: Firm did not perform process validation.
| Recall number | D-0435-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SSM Health Care St. Louis DBA SSM St. Clare Health Center, Fenton, MO, United States |
| Recall initiated | 2024-02-29 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Distributed | MO |
| Quantity | 11,798 syringes |
| Reason classes | sterility |
| NDC | 60652-0104-01 |
| Lot numbers | 20230912-847E0C, 20231010-3D0B35, 20231101-09C52B, 20231115-2FF64D, 20231121-20F8BB, 20231219-08D09D, 20240109-837CB8 |
| Expiration dates | 2024-03-10, 2024-04-07, 2024-04-29, 2024-05-13, 2024-05-19, 2024-06-16, 2024-07-07 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0435-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.