Reported Apr 10, 2024 · Ongoing
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This…
SSM Health Care St. Louis dba SSM St. Clare Health Center
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SSM Health Care St. Louis DBA SSM St. Clare Health Center · 1015 Bowles Ave · Fenton, MO · 63026-2394
Is this the product you have?
- 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
- NDC60652-0104-1
- Lot codes and dates
Lot #s: 20240109-837CB8Exp. 07-Jul-202420231219-08D09DExp. 16-Jun-202420231121-20F8BBExp. 19-May-202420231115-2FF64DExp. 13-May-202420231101-09C52BExp. 29-Apr-202420231010-3D0B35Exp. 07-Apr-202420230912-847E0CExp. 10-Mar-2024
- Amount recalled
- 11,798 syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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