FDA Recall D-0435-2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center · Fenton, MO
Class II Ongoing 805 days on record
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.
Recall record
- Recall number
D-0435-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- MO
- Recall initiated
- 2024-02-29
- Classified by FDA Center
- 2024-04-04
- FDA published
- 2024-04-10
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Firm location
- Fenton, MO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.