Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations:
Eye Drops & Ophthalmic Recalls
Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
673 recalls in this category, newest first.
Class II · Moderate risk
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates
CGMP Deviations:
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Levofloxacin Ophthalmic Solution 0.5%
CGMP Deviations:
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
GONAK Hypromellose Ophthalmic Demulcent Solution
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP 0.5%
CGMP Deviations:
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Betaxolol Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears OINTMENT
CGMP Deviations:
Class II · Moderate risk
Class II · Moderate risk
GLYCERIN OPHTHALMIC DROPS 98.5% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class II · Moderate risk
Pataday
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
GenTeal Tears
CGMP Deviations: products were stored outside the drug label specifications.
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