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
Reported: April 10, 2024 Initiated: February 29, 2024 #D-0435-2024
Product Description
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.
Details
- Recalling Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Units Affected
- 11,798 syringes
- Distribution
- MO
- Location
- Fenton, MO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center. Units affected: 11,798 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm did not perform process validation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2024. Severity: Moderate. Recall number: D-0435-2024.
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