{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rochester",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206586"
        ],
        "brand_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "42023-179"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "238129"
        ],
        "spl_id": [
          "b97759b6-6b4d-4989-a41c-916270fb2660"
        ],
        "spl_set_id": [
          "34767dda-ce52-4f98-a45f-bb5cee0cd5e6"
        ],
        "package_ndc": [
          "42023-179-05",
          "42023-179-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "56W8MW3EN1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77169",
      "recalling_firm": "PAR Sterile Products LLC",
      "address_1": "870 Parkdale Rd",
      "address_2": "N/A",
      "postal_code": "48307-1740",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0698-2017",
      "product_description": "Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY  10977.",
      "product_quantity": "122,469 cartons",
      "reason_for_recall": "Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.",
      "recall_initiation_date": "20170428",
      "center_classification_date": "20170509",
      "termination_date": "20180329",
      "report_date": "20170517",
      "code_info": "Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18."
    }
  ]
}