Home / Recalls / SSM Health Care St. Louis DBA SSM St. Clare Health Center / D-0435-2024

D-0435-2024 Class II Ongoing

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

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
11,798 syringes

Product Description

Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1

Reason for Recall

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

Distribution Pattern

MO

Code Information

Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.

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-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-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-0144-2018 Class II — Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentrati (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)
  • D-0143-2018 Class II — Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: (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)