Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
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
Azelastine HCl Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Lubricant Eye Drops Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Artificial Tears Ophthalmic Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
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
Ciprofloxacin Ophthalmic Solution USP
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 III · Low risk
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
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 I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class III · Low risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
LABELING: LABEL MIX-UP
Class III · Low risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops
LABELING: LABEL MIX-UP
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
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 III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
LITE Regener-Eyes
Lack of Sterility Assurance
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
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
Timolol Maleate Ophthalmic Solution USP
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
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
Temperature abuse: Products exposed to improper temperature above drug label specifications.
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