{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA204021"
        ],
        "brand_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-430",
          "43386-432",
          "43386-433",
          "43386-434",
          "43386-431"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OXYCODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1049611",
          "1049618",
          "1049621",
          "1049683",
          "1049686"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "43386-432-01",
          "43386-432-03",
          "43386-432-05",
          "43386-433-01",
          "43386-433-03",
          "43386-433-05",
          "43386-430-01",
          "43386-430-05",
          "43386-430-03",
          "43386-434-01",
          "43386-434-05",
          "43386-434-03",
          "43386-431-01",
          "43386-431-03",
          "43386-431-05"
        ],
        "is_original_packager": [
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        ],
        "upc": [
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          "0343386434039",
          "0343386430031",
          "0343386432059",
          "0343386431052",
          "0343386430017",
          "0343386433032",
          "0343386433018",
          "0343386431038",
          "0343386432011",
          "0343386432035",
          "0343386431014"
        ],
        "unii": [
          "C1ENJ2TE6C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89324",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product Distributed in NY and OH.",
      "recall_number": "D-0358-2022",
      "product_description": "Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01",
      "product_quantity": "23,965 100 count bottles",
      "reason_for_recall": "Out-of-specification impurity test result observed at 18-month long term stability time point.",
      "recall_initiation_date": "20211229",
      "center_classification_date": "20220105",
      "termination_date": "20220823",
      "report_date": "20220112",
      "code_info": "Lot # S000268, Exp. date January 2022"
    }
  ]
}