1. Home
  2. Drug Recall Enforcement Reports
  3. Recall Enforcement Event ID: 96741

Recall Enforment Report D-0404-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by BRS Analytical Services, LLC, originally initiated on 04-23-2025 for the product Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15. The product was recalled due to cgmp deviations and lack of assurance of sterility.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0404-202504-23-202505-14-2025Class II13,872 cases (24 cartons per case)Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.cGMP deviations and lack of assurance of sterility.Ongoing
D-0407-202504-23-202505-14-2025Class II13,104 cases (24 cartons per case)Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.cGMP deviations and lack of assurance of sterility.Ongoing
D-0405-202504-23-202505-14-2025Class II1,610 cases (24 cartons per case)Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.cGMP deviations and lack of assurance of sterility.Ongoing
D-0408-202504-23-202505-14-2025Class II14,333 cases (24 cartons per case)Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.cGMP deviations and lack of assurance of sterility.Ongoing
D-0406-202504-23-202505-14-2025Class II32,876 cases (24 cartons per case)Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.cGMP deviations and lack of assurance of sterility.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
50268-043Artificial Tears Artificial TearsSolution/ DropsOphthalmicAvpakHuman Otc Drug
50268-066Carboxymethylcellulose Sodium Carboxymethylcellulose SodiumGelOphthalmicAvpakHuman Otc Drug
50268-068Carboxymethylcellulose Sodium Carboxymethylcellulose SodiumSolution/ DropsOphthalmicAvpakHuman Otc Drug
50268-126Lubricant Eye Drops Solution Polyethylene Glycol 400 And Propylene GlycolSolutionOphthalmicAvpakHuman Otc Drug
50268-678Polyvinyl Alcohol Polyvinyl AlcoholSolution/ DropsOphthalmicAvpakHuman Otc Drug