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- Recall Enforcement Event ID: 93357
Recall Enforment Report D-0291-2024
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Kilitch Healthcare India Limited, originally initiated on 11-13-2023 for the product Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 The product was recalled due to non-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-0291-2024 | 11-13-2023 | 02-14-2024 | Class I | 210,192 bottles | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 | Non-Sterility | Ongoing |
D-0302-2024 | 11-13-2023 | 02-14-2024 | Class I | 2,820 bottles | Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30 | Non-Sterility | Ongoing |
D-0296-2024 | 11-13-2023 | 02-14-2024 | Class I | 253,080 bottles | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15 | Non-Sterility | Ongoing |
D-0294-2024 | 11-13-2023 | 02-14-2024 | Class I | 110,832 bottles | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10 | Non-Sterility | Ongoing |
D-0308-2024 | 11-13-2023 | 02-14-2024 | Class I | 9,216 bottles | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3 | Non-Sterility | Ongoing |
D-0301-2024 | 11-13-2023 | 02-14-2024 | Class I | 14,784 bottles | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1 | Non-Sterility | Ongoing |
D-0304-2024 | 11-13-2023 | 02-14-2024 | Class I | 6,024 bottles | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5 | Non-Sterility | Ongoing |
D-0300-2024 | 11-13-2023 | 02-14-2024 | Class I | 401,568 bottles | Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403 | Non-Sterility | Ongoing |
D-0292-2024 | 11-13-2023 | 02-14-2024 | Class I | 137,784 bottles | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
D-0310-2024 | 11-13-2023 | 02-14-2024 | Class I | 56,520 bottles | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94 | Non-Sterility | Ongoing |
D-0298-2024 | 11-13-2023 | 02-14-2024 | Class I | 150,720 bottles | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
D-0297-2024 | 11-13-2023 | 02-14-2024 | Class I | 10,944 bottles | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1 | Non-Sterility | Ongoing |
D-0303-2024 | 11-13-2023 | 02-14-2024 | Class I | 33,984 bottles | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01 | Non-Sterility | Ongoing |
D-0293-2024 | 11-13-2023 | 02-14-2024 | Class I | 1,492,344 bottles | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94 | Non-Sterility | Ongoing |
D-0311-2024 | 11-13-2023 | 02-14-2024 | Class I | 137,544 bottles | Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30 | Non-Sterility | Ongoing |
D-0307-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,776 bottles | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3 | Non-Sterility | Ongoing |
D-0299-2024 | 11-13-2023 | 02-14-2024 | Class I | 23,208 bottles | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1 | Non-Sterility | Ongoing |
D-0309-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,296 bottles | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid | Non-Sterility | Ongoing |
D-0306-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,200 bottles | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5 | Non-Sterility | Ongoing |
D-0305-2024 | 11-13-2023 | 02-14-2024 | Class I | 45,408 bottles | CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15 | Non-Sterility | Ongoing |
D-0290-2024 | 11-13-2023 | 02-14-2024 | Class I | 386,256 bottles | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
D-0295-2024 | 11-13-2023 | 02-14-2024 | Class I | 12,960 bottles | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1 | Non-Sterility | Ongoing |