HYDROmorphone HCl 10 mg in 0 recalled over manufacturing violations

Recall date

May 9, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outso…

Recall number

D-0776-2023

FDA classification

Class II

Brand / firm

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

Sold / distributed

Product was distributed in Missouri.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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