Home / Recalls / SSM Health Care St. Louis DBA SSM St. Clare Health Center / D-0436-2024

D-0436-2024 Class II Ongoing

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

FDA drug recall D-0436-2024 was initiated by SSM Health Care St. Louis DBA SSM St. Clare Health Center on February 29, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Firm did not perform process validation. The recall status is ongoing. Affected quantity: 140 vials.

Recall Details

Product Type
Drugs
Report Date
April 10, 2024
Initiation Date
February 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 vials

Product Description

FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1

Reason for Recall

Lack of Assurance of Sterility: Firm did not perform process validation.

Distribution Pattern

MO

Code Information

Lot: 20231031-0C91D9, Exo 29-Feb-2024.

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

  • D-0435-2024 Class II — Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, (February 29, 2024)
  • D-0776-2023 Class II — HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx (May 9, 2023)
  • 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-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)
  • D-0136-2018 Class II — Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/m (August 10, 2017)

FDA data resources