{
  "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": [
          "ANDA201633"
        ],
        "brand_name": [
          "BUPRENORPHINE AND NALOXONE"
        ],
        "generic_name": [
          "BUPRENORPHINE AND NALOXONE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-969",
          "62756-970"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBLINGUAL"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE",
          "NALOXONE HYDROCHLORIDE DIHYDRATE"
        ],
        "rxcui": [
          "351266",
          "351267"
        ],
        "spl_id": [
          "cbeda871-3722-4395-a97f-b614b5406675"
        ],
        "spl_set_id": [
          "91b68606-05de-4586-ae31-07e8cc9160cf"
        ],
        "package_ndc": [
          "62756-969-83",
          "62756-969-64",
          "62756-970-83",
          "62756-970-64"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756969834"
        ],
        "unii": [
          "56W8MW3EN1",
          "5Q187997EE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91033",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide with the United States",
      "recall_number": "D-0024-2023",
      "product_description": "Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only,  Distributed by:  Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Substance",
      "recall_initiation_date": "20221018",
      "center_classification_date": "20221031",
      "termination_date": "20230907",
      "report_date": "20221109",
      "code_info": "Lot #: DNC1129A, Exp 06/2023 Lot #: DNC1740A, Exp 09/2023"
    }
  ]
}