SSM Health Care St. Louis DBA SSM St. Clare Health Center 2024-04-10 Health serious FDA
Health · FDA · Recall #FDA-D-0435-2024
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only,… Recall
Issued April 10, 2024 · SSM Health Care St. Louis DBA SSM St. Clare Health Center
In April 2024, SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled the Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: Firm did not perform process validation.
What you should do
- 1 Stop using Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SSM Health Care St. Louis DBA SSM St. Clare Health Center to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Category
- Health
- Recall date
- April 10, 2024
- Units affected
- Not reported
- Sold at
- MO
- Recall number
- FDA-D-0435-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- SSM Health Care St. Louis DBA SSM St. Clare Health Center has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.