{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "brand_name": [
          "OPIUM TINCTURE DEODORIZED"
        ],
        "generic_name": [
          "MORPHINE"
        ],
        "manufacturer_name": [
          "Edenbridge Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "42799-217"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MORPHINE"
        ],
        "rxcui": [
          "830196"
        ],
        "spl_id": [
          "46e15fdb-940a-7018-e063-6294a90a9cc1"
        ],
        "spl_set_id": [
          "e2a5697a-cc41-4cf1-b3a8-59b0268740d7"
        ],
        "package_ndc": [
          "42799-217-01",
          "42799-217-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175684",
          "N0000175690"
        ],
        "pharm_class_moa": [
          "Full Opioid Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "Opioid Agonist [EPC]"
        ],
        "unii": [
          "76I7G6D29C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93236",
      "recalling_firm": "Edenbridge Pharmaceuticals, LLC",
      "address_1": "1 Upper Pond Rd",
      "address_2": "Ste 250",
      "postal_code": "07054-1050",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0080-2024",
      "product_description": "Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01",
      "product_quantity": "4548 bottles",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20231020",
      "center_classification_date": "20231030",
      "termination_date": "20240816",
      "report_date": "20231108",
      "code_info": "Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026"
    }
  ]
}