{
  "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": "2026-03-18",
    "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": [
          "7490df67-56c0-4a1c-8533-2107f3e8aea5"
        ],
        "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": "81888",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0375-2019",
      "product_description": "Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA",
      "product_quantity": "287,784 bottles",
      "reason_for_recall": "CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.",
      "recall_initiation_date": "20190102",
      "center_classification_date": "20190115",
      "termination_date": "20200626",
      "report_date": "20190116",
      "code_info": "a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019   b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019;  F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.",
      "more_code_info": ""
    }
  ]
}