Class II · Moderate risk
Cyclo/PE/Tropic/Ketor
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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
Cyclo/PE/Trop PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Acetylcysteine 10% Ophtalmic
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Falied pH specification
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Class II · Moderate risk
Blephamide
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
FML (fluorometholone ophthalmic ointment)
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh P.M.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh Lacri-Lube
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Bromfenac Ophthalmic Solution
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
Tobramycin 14 mg/mL Ophthalmic Solution
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Vancomycin 25 mg/ml Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin 0.03% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin 0.02% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Failed pH specification
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Rose Bengal GloStrips
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class II · Moderate risk
EDTA 3% Eye Drops
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class III · Low risk
Bromfenac Ophthalmic Solution 0.09%
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class III · Low risk
Eye Drops Advanced Relief
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
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