Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation 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 III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Lack of Assurance of Sterility.
Class II · Moderate risk
Lidocaine Ophthalmic Gel 3.5%
Lack of Assurance of Sterility.
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk
Vit C/Gsh 1.25%-1.25% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate 0.5% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate 0.01% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Phenylephrine 2.5%
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Refresh Tears
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class II · Moderate risk
Sato Clear
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Optic Splash
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class III · Low risk
Levofloxacin Ophthalmic Solution
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Lack of Sterility Assurance
Class II · Moderate risk
Sodium Chloride Ophthalmic Solution
Subpotent Drug: concentration of product is less than labeled amount.
Class II · Moderate risk
Travoprost Ophthalmic Solution USP
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Class II · Moderate risk
Ceftazidime
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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