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FDARecalled Jun 7, 2023 · #D-0776-2023

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

Hazard

Class II — temporary health risk

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Description

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. Classification: Class II Distribution: Product was distributed in Missouri.

Product details

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
Type
Drugs
Manufacturer
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Model numbers
20230222-45AB24, 20230110-058361, 20221208-0F5483, 20221109-45BA60, 20220929-523FD5, 20220914-5D5AE0, 220502-024, 220510-035, 220526-015, 220811-010
UPCs