Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
vancomycin added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
norepinephrine 4 mg added to dextrose 5% 250 mL*
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
dilTIAZem added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
dilTIAZem added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 60 units added to 0.9% sodium chloride 1
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 20 units added to 0.9% sodium chloride 1
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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