Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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 I · High risk
LEADER brand Dry Eye Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Eye Irritation Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Lubricating Tears Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 4% ophthalmic solution
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium chloride Solution for Intravenous Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Cefuroxime 4mg /0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate 2.5% solution for inhalation
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate Ophthalmic Irrigation Solution 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% sodium chloride
Lack of assurance of sterility:
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