Home / Recalls / SSM Health Care St. Louis DBA SSM St. Clare Health Center / D-0776-2023

D-0776-2023 Class II Ongoing

Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center — Fenton, MO

FDA drug recall D-0776-2023 was initiated by SSM Health Care St. Louis DBA SSM St. Clare Health Center on May 9, 2023 and is designated Class II. 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 represente… The recall status is ongoing. Affected quantity: 3,232 syringes.

Recall Details

Product Type
Drugs
Report Date
June 7, 2023
Initiation Date
May 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,232 syringes

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

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 Pattern

Product was distributed in Missouri.

Code Information

Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023

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

  • D-0436-2024 Class II — FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL T (February 29, 2024)
  • D-0435-2024 Class II — Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, (February 29, 2024)
  • D-0007-2022 Class II — Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only (September 22, 2021)
  • D-0137-2018 Class II — Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, T (August 10, 2017)
  • D-0145-2018 Class II — Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This (August 10, 2017)
  • D-0138-2018 Class II — Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL ba (August 10, 2017)
  • D-0139-2018 Class II — HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentr (August 10, 2017)
  • D-0142-2018 Class II — Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg (August 10, 2017)
  • D-0141-2018 Class II — Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This (August 10, 2017)
  • D-0140-2018 Class II — Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: (August 10, 2017)

FDA data resources