{
  "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": "Monmouth Junction",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203518"
        ],
        "brand_name": [
          "MORPHINE SULFATE"
        ],
        "generic_name": [
          "MORPHINE SULFATE"
        ],
        "manufacturer_name": [
          "Cranbury Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "27808-082",
          "27808-084"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "892589",
          "892625"
        ],
        "spl_id": [
          "68c7aa49-1577-45cf-90a5-800070d824eb"
        ],
        "spl_set_id": [
          "d8598654-94ad-4cfb-81d2-9b68e013a428"
        ],
        "package_ndc": [
          "27808-084-01",
          "27808-084-02",
          "27808-082-01",
          "27808-082-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0327808082015",
          "0327808082022"
        ],
        "unii": [
          "X3P646A2J0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77798",
      "recalling_firm": "Tris Pharma Inc.",
      "address_1": "2033 US Highway 130",
      "address_2": "N/A",
      "postal_code": "08852-3003",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-1126-2017",
      "product_description": "Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01",
      "product_quantity": "34,824 bottles",
      "reason_for_recall": "Defective container: Oral solution leaking from container.",
      "recall_initiation_date": "20170615",
      "center_classification_date": "20170829",
      "termination_date": "20171108",
      "report_date": "20170906",
      "code_info": "Lot #: 08215001A, Exp  6/30/2017; 08215002A, 08215004A, Exp 7/31/2017"
    }
  ]
}