Class II · Moderate risk
Moxifloxacin 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
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk
Brinzolamide Ophthalmic Suspension
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine (povidone-iodine)
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Lidocaine
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Mvasi
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin-C
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin-C Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL / Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium
Lack of Assurance of Sterility
Class II · Moderate risk
Edetate Disodium
Lack of Assurance of Sterility.
Class II · Moderate risk
Cefuroxime
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftazidime
Lack of Assurance of Sterility
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II · Moderate risk
Betaxolol Ophthalmic Solution
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II · Moderate risk
TheraTears Extra
Lack of Assurance of Sterility
Class II · Moderate risk
Spironolactone Ophthalmic Solution 0.005 mg/mL
Lack of Assurance of Sterility
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