{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208915"
        ],
        "brand_name": [
          "CINACALCET"
        ],
        "generic_name": [
          "CINACALCET"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-410",
          "69097-411",
          "69097-412"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CINACALCET HYDROCHLORIDE"
        ],
        "rxcui": [
          "432400",
          "432401",
          "432402"
        ],
        "spl_id": [
          "383a7dc8-b195-4868-8774-f16a5558771e"
        ],
        "spl_set_id": [
          "02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"
        ],
        "package_ndc": [
          "69097-410-02",
          "69097-411-02",
          "69097-412-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K860WSG25"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98670",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0449-2026",
      "product_description": "Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC:  69097-410-02",
      "product_quantity": "113,336 bottles",
      "reason_for_recall": "CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit",
      "recall_initiation_date": "20260316",
      "center_classification_date": "20260410",
      "report_date": "20260422",
      "code_info": "Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027"
    }
  ]
}