Class II · Moderate risk
Systane Zaditor
CGMP Deviations: products were stored outside the drug label specifications.
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
Systane Balance
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Medic Eye Drops Max Redness Sku 998920 Clr Eys Mx Rdns Rlif 0.5…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Tetracaine Hydrochloride Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Pilocarpine HCL Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Tropicamide Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
Prednisolone Acetate Ophthalmic Suspension
cGMP deviations: Temperature abuse
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Isopto Atropine
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Aparaclonidine Ophthalmic Solution 0.5% as base
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betadine 5%
cGMP deviations: Temperature abuse
Class II · Moderate risk
TobraDex (tobramycin and dexamethasone)
cGMP deviations: Temperature abuse
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class II · Moderate risk
Travoprost Ophthalmic Solution
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
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