{
  "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": "Ongoing",
      "city": "Raleigh",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211892"
        ],
        "brand_name": [
          "CINACALCET"
        ],
        "generic_name": [
          "CINACALCET"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc."
        ],
        "product_ndc": [
          "16729-440",
          "16729-441",
          "16729-442"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CINACALCET HYDROCHLORIDE"
        ],
        "rxcui": [
          "432400",
          "432401",
          "432402"
        ],
        "spl_id": [
          "40aa0834-3fd8-c230-e063-6294a90a800d"
        ],
        "spl_set_id": [
          "6bad4e06-c0a1-4123-83c2-67d3b081e8a9"
        ],
        "package_ndc": [
          "16729-440-10",
          "16729-440-15",
          "16729-440-01",
          "16729-441-10",
          "16729-441-15",
          "16729-441-01",
          "16729-442-10",
          "16729-442-15",
          "16729-442-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "1K860WSG25"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95501",
      "recalling_firm": "ACCORD HEALTHCARE, INC.",
      "address_1": "8041 Arco Corporate Dr Ste 200",
      "address_2": "N/A",
      "postal_code": "27617-2010",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and PR",
      "recall_number": "D-0030-2025",
      "product_description": "Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.",
      "recall_initiation_date": "20241010",
      "center_classification_date": "20241031",
      "report_date": "20241106",
      "code_info": "a) Lot #:             Expiry Date: M2118190        11/2024 M2201091        11/2024 M2206241             11/2024 M2206451             04/2025 M2208674             06/2025 M2213850             08/2025 M2215221             09/2025 M2216236             11/2025 M2217098             11/2025 M2300664             11/2025  b) Lot #:           Expiry Date: M2210808            06/2025 M2212212            08/2025 M2214435            09/2025 M2217097            11/2025 M2301921            01/2026",
      "more_code_info": ""
    }
  ]
}