{
  "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-0031-2025",
      "product_description": "Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, 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: M2204481              02/2025 M2212389              08/2025 M2214271              09/2025 M2215970              10/2025 M2216458              10/2025  b) Lot #:             Expiry Date: M2212869           08/2025 M2216362           09/2025 M2215969           10/2025",
      "more_code_info": ""
    }
  ]
}