{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rochester",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206586"
        ],
        "brand_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "generic_name": [
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        "product_ndc": [
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        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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          "INTRAVENOUS"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "rxcui": [
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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        ],
        "is_original_packager": [
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        "unii": [
          "56W8MW3EN1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98610",
      "recalling_firm": "ENDO USA, Inc.",
      "address_1": "870 Parkdale Rd",
      "address_2": "",
      "postal_code": "48307-1740",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0527-2026",
      "product_description": "Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.",
      "product_quantity": "34,293 vials",
      "reason_for_recall": "Presence of particulate matter: identified as Buprenorphine free base",
      "recall_initiation_date": "20260313",
      "center_classification_date": "20260511",
      "report_date": "20260520",
      "code_info": "Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027",
      "more_code_info": ""
    }
  ]
}