{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Pomona", "state": "CA", "country": "United States", "classification": "Class II", "openfda": { "application_number": [ "M018" ], "brand_name": [ "ARTIFICIAL TEARS", "RITE AID EYE DROPS DRY EYE RELIEF", "LEADER DRY EYE RELIEF EYE DROPS", "FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS", "MEIJER DRY EYE RELIEF", "GNP EYE DROPS DRY EYE RELIEF" ], "generic_name": [ "GLYCERIN", "GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400", "POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL" ], "manufacturer_name": [ "Geri-Care Pharmaceuticals, Corp", "Rite Aid Corporation", "CARDINAL HEALTH 110, LLC. DBA LEADER", "Strategic Sourcing Services LLC", "Meijer Distribution, Inc.", "AmerisourceBergen" ], "product_ndc": [ "57896-181", "11822-1067", "70000-0502", "70677-1158", "41250-718", "46122-605" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "GLYCERIN", "HYPROMELLOSES", "POLYETHYLENE GLYCOL 400", "HYPROMELLOSE, UNSPECIFIED", "TETRAHYDROZOLINE HYDROCHLORIDE" ], "rxcui": [ "259581", "996209" ], "spl_id": [ "472b069b-4e80-8cb8-e063-6294a90a302b", "0d385aa4-0522-b4c5-e063-6294a90a65f8", "4c26604a-a018-ceb5-e063-6394a90a27a3", "474922b2-773c-4cff-e063-6394a90a6b3a", "0d22e47a-248f-46d1-e063-6294a90ab3c2", "53536b7c-37a2-51fb-e063-6294a90a5be6" ], "spl_set_id": [ "7cc437e3-bad9-59be-e053-2991aa0a1da3", "fa1b5b66-9643-e9a7-e053-6394a90ae3cf", "2ded4bda-b3c3-4521-8701-5c8446fd148b", "0019cd99-b245-2ffc-e063-6294a90a9f27", "9feaa5e2-6aca-96e8-e053-2a95a90a54bd", "9b5b5213-3982-224d-e053-2995a90a1208" ], "package_ndc": [ "57896-181-05", "11822-1067-2", "70000-0502-1", "70000-0502-2", "70677-1158-1", "41250-718-01", "46122-605-05" ], "is_original_packager": [ true ], "upc": [ "0357896184056", "0011822106702", "0096295137064", "0096295137071", "0010939958273", "0713733296922", "0087701432019", "036800361003", "093351011566", "041220437412", "095072026560", "072036713032", "614299056206" ], "nui": [ "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417" ], "pharm_class_epc": [ "Non-Standardized Chemical Allergen [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]" ], "pharm_class_cs": [ "Allergens [CS]", "Glycerol [CS]" ], "unii": [ "PDC6A3C0OX", "3NXW29V3WO", "B697894SGQ", "0YZT43HS7D" ] }, "product_type": "Drugs", "event_id": "98533", "recalling_firm": "K.C. Pharmaceuticals, Inc", "address_1": "3420 Pomona Blvd", "address_2": "", "postal_code": "91768-3236", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "E-Mail", "distribution_pattern": "Nationwide in the US", "recall_number": "D-0411-2026", "product_description": "Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05", "product_quantity": "1,023,096 bottles", "reason_for_recall": "Lack of Assurance of Sterility", "recall_initiation_date": "20260303", "center_classification_date": "20260331", "report_date": "20260408", "code_info": "Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01, Exp.: 06/30/26; m)", "more_code_info": "" } ] }