Class II · Moderate risk
potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
norepinephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 20 units added to Lactated Ringer's 1000 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
neostigmine 5 mg/5mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 7500 units added to 0.9% sodium chloride 1000mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 5000 units/500mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 4000 units/1000mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 20 units added to 0.9% sodium chloride 1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 15 units added to Lactated Ringer's 250 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 2500 units added to 0.9% sodium chloride 250mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
oxyTOCIN 10 units added to Lactated Ringer's 500 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 2 g/500 mL added to 0.9% Sodium Chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.75g added to 0.9% sodium chloride 500mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.5 g/250mL added to 5% dextrose
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
vancomycin 1.5 g/250 mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PHENYLephrine 1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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