Class II · Moderate risk
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment
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
Serum Tears 20% Eye Drops PF Solution
Lack of Assurance of Sterility.
Class II · Moderate risk
Riboflavin 0.1% Ophthalmic Solution Syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Brilliant Blue Ophthalmic PF INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class III · Low risk
Lotemax (loteprednol etabonate ophthalmic gel 0.5%)
Failed Stability Specifications: Out of specification for viscosity.
Class II · Moderate risk
Interferon 1 Million IU/mL Eye Drops
Lack of sterility assurance.
Class II · Moderate risk
Serum Tears 50% Ophthalmic Drops
Lack of sterility assurance.
Class II · Moderate risk
Polyhexamethylene Biguanide 0.02% Ophthalmic Drops
Lack of sterility assurance.
Class II · Moderate risk
Methylprednisolone 1% PF Ophthalmic
Lack of sterility assurance.
Class II · Moderate risk
Amphotericin B 0.15% Eye Drops
Lack of sterility assurance.
Class II · Moderate risk
Atropine 0.01% Eye Drops
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer
Lack of sterility assurance.
Class II · Moderate risk
Class II · Moderate risk
Red Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
Dry Eye
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk
15% Msm
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk
Acetyl-L-Cysteine 10% P.F. Ophth Solution
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Dexamethasone
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Cefuroxime 10 mg/mL in Sodium Chloride
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class II · Moderate risk
Moisturizing Lubricant Eye Drops
Failed Stability Specification: out of specification results for Sodium Perborate
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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