Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FentaNYL citrate Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center Due to Lack of Assurance of Sterility: Firm did not...

Date: February 29, 2024
Company: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SSM Health Care St. Louis DBA SSM St. Clare Health Center directly.

Affected Products

FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1

Quantity: 140 vials

Why Was This Recalled?

Lack of Assurance of Sterility: Firm did not perform process validation.

Where Was This Sold?

This product was distributed to 1 state: MO

Affected (1 state)Not affected

About SSM Health Care St. Louis DBA SSM St. Clare Health Center

SSM Health Care St. Louis DBA SSM St. Clare Health Center has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report