Eye Drops & Ophthalmic Recalls
Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk Ongoing
Reason Incorrect Product Formulation
Class III · Low risk Ongoing
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Reason Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class III · Low risk Completed
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk Ongoing
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Reason cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk Ongoing
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle