{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Elmwood Park",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077535"
        ],
        "brand_name": [
          "ONDANSETRON"
        ],
        "generic_name": [
          "ONDANSETRON"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-105",
          "68462-106",
          "68462-157",
          "68462-158"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "rxcui": [
          "104894",
          "198052",
          "312086",
          "312087"
        ],
        "spl_id": [
          "32177a6a-8c35-4e1c-b7f5-7376b1c1316a"
        ],
        "spl_set_id": [
          "eee5217a-eba8-463a-812d-bf3c66f0934f"
        ],
        "package_ndc": [
          "68462-105-33",
          "68462-105-30",
          "68462-106-33",
          "68462-106-30",
          "68462-157-13",
          "68462-158-11",
          "68462-158-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462157138",
          "0368462106303",
          "0368462105306",
          "0368462158111"
        ],
        "nui": [
          "N0000175817",
          "N0000175818"
        ],
        "pharm_class_moa": [
          "Serotonin 3 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Serotonin-3 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "NMH84OZK2B",
          "4AF302ESOS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98233",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "619 River Dr",
      "address_2": "N/A",
      "postal_code": "07407-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0246-2026",
      "product_description": "Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13",
      "product_quantity": "96,948 packs",
      "reason_for_recall": "Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.",
      "recall_initiation_date": "20251230",
      "center_classification_date": "20251231",
      "report_date": "20260107",
      "code_info": "Lot #: 19251311, Exp Date April 2027"
    }
  ]
}