{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA065259"
        ],
        "brand_name": [
          "CEFDINIR"
        ],
        "generic_name": [
          "CEFDINIR"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-722",
          "68180-723"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CEFDINIR"
        ],
        "rxcui": [
          "309054",
          "476576"
        ],
        "spl_id": [
          "b32b7bfb-4770-4da0-8c48-684233cd10c9"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "68180-722-20",
          "68180-722-10",
          "68180-722-04",
          "68180-722-05",
          "68180-723-20",
          "68180-723-10",
          "68180-723-04",
          "68180-723-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180723042"
        ],
        "nui": [
          "N0000175488",
          "M0003827"
        ],
        "pharm_class_epc": [
          "Cephalosporin Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Cephalosporins [CS]"
        ],
        "unii": [
          "CI0FAO63WC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94492",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-0497-2024",
      "product_description": "Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04",
      "product_quantity": "17,040 bottles",
      "reason_for_recall": "Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.",
      "recall_initiation_date": "20240424",
      "center_classification_date": "20240514",
      "termination_date": "20250429",
      "report_date": "20240522",
      "code_info": "Lot # F305292, Exp 8/30/2025"
    }
  ]
}