{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215458"
        ],
        "brand_name": [
          "OMEGA-3-ACID ETHYL ESTERS"
        ],
        "generic_name": [
          "OMEGA-3-ACID ETHYL ESTERS CAPSULES"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-7495"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OMEGA-3-ACID ETHYL ESTERS"
        ],
        "rxcui": [
          "577208"
        ],
        "spl_id": [
          "aafd4810-3468-4b20-9d96-df37cc74a524"
        ],
        "spl_set_id": [
          "e40d55f2-db9f-4a48-8639-9aa7491e4de5"
        ],
        "package_ndc": [
          "0904-7495-06"
        ],
        "original_packager_product_ndc": [
          "70756-423"
        ],
        "unii": [
          "D87YGH4Z0Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98763",
      "recalling_firm": "The Harvard Drug Group LLC",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0493-2026",
      "product_description": "Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288.  NDC: 0904-7495-06",
      "product_quantity": "2,238 5 x 10 unit dose cartons",
      "reason_for_recall": "Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.",
      "recall_initiation_date": "20260409",
      "center_classification_date": "20260424",
      "report_date": "20260429",
      "code_info": "Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026",
      "more_code_info": ""
    }
  ]
}