FDA-Drug2023-06-07Class II
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
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Hazard
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.
Sold states
Product was distributed in Missouri.
Affected count
3,232 syringes
Manufactured in
1015 Bowles Ave, N/A, Fenton, MO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2023Don't want to check this manually?
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