FDA recall D-0776-2023

SSM Health Care St. Louis DBA SSM St. Clare Health Center · Class II · drug

Product

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

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.

Distribution

Product was distributed in Missouri.

Key facts

Status
Ongoing
Initiation date
2023-05-09
Report date
2023-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2023