SSM Health Care St. Louis DBA SSM St. Clare Health Center: Drug Recall

Recall #D-0776-2023 · 05/09/2023

Class II: Risk

Recall Details

Recall Number: D-0776-2023
Classification: Class II
Product Type: Drug
Recalling Firm: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Status: Ongoing
Date Initiated: 05/09/2023
Location: Fenton, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,232 syringes

Reason for Recall

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Product Description

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

Distribution Pattern

Product was distributed in Missouri.

Other Recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Class II: Risk 02/29/2024

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 02/29/2024

Lack of Assurance of Sterility: Firm did not perform process validation.
Class II: Risk 09/22/2021

Lack of Assurance of Sterility

View all recalls by SSM Health Care St. Louis DBA SSM St. Clare Health Center →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.