Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
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 III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class II · Moderate risk
octiq Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
MAJOR LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
Dr. Berne's Organic Castor Oil Eye Drops
CGMP Deviations
Class III · Low risk
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class II · Moderate risk
Dry Eye Relief Lubricant Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Original Eye Drops
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Class II · Moderate risk
Travoprost Ophthalmic Solution
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
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