{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "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": [
          "32a7af7e-3f90-4881-9075-473644237017"
        ],
        "spl_set_id": [
          "34767dda-ce52-4f98-a45f-bb5cee0cd5e6"
        ],
        "package_ndc": [
          "42023-179-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "56W8MW3EN1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99237",
      "recalling_firm": "Par Health USA, LLC",
      "address_1": "870 Parkdale Rd",
      "address_2": "",
      "postal_code": "48307-1740",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0596-2026",
      "product_description": "Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355,  NDC 42023-179-05",
      "product_quantity": "46,334 units",
      "reason_for_recall": "Crystallization; identified as Buprenorphine free base",
      "recall_initiation_date": "20260612",
      "center_classification_date": "20260617",
      "report_date": "20260624",
      "code_info": "Lot #:  82886, exp 09/30/2026; 89646, exp 05/31/2027",
      "more_code_info": ""
    }
  ]
}