Home / Recalls / SSM Health Care St. Louis DBA SSM St. Clare Health Center / D-0138-2018

D-0138-2018 Class II Terminated

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

FDA drug recall D-0138-2018 was initiated by SSM Health Care St. Louis DBA SSM St. Clare Health Center on August 10, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorga… The recall status is terminated (terminated March 22, 2018). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
January 3, 2018
Initiation Date
August 10, 2017
Termination Date
March 22, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01

Reason for Recall

Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

Distribution Pattern

SSM Health entities in the state of MO only

Code Information

Lot, exp: 170621-008, 09/19/2017; 170703-002, 10/01/2017; 170711-031, 10/09/2017

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-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-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