{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201760"
        ],
        "brand_name": [
          "BUPRENORPHINE"
        ],
        "generic_name": [
          "BUPRENORPHINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-459",
          "62756-460"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBLINGUAL"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "351264",
          "351265"
        ],
        "spl_id": [
          "ba293490-0f6f-4400-82cd-3af9774839e8"
        ],
        "spl_set_id": [
          "9fd1f18f-0b0f-4059-b603-19ecbf0ed63a"
        ],
        "package_ndc": [
          "62756-459-83",
          "62756-459-64",
          "62756-460-83",
          "62756-460-64"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "56W8MW3EN1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92256",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 19 distributors nationwide.",
      "recall_number": "D-0869-2023",
      "product_description": "Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.",
      "product_quantity": "12,336 bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20230503",
      "center_classification_date": "20230607",
      "termination_date": "20240109",
      "report_date": "20230614",
      "code_info": "Lot #: DND1515A, Exp 08/24",
      "more_code_info": ""
    }
  ]
}