{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cherry Hill",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018565"
        ],
        "brand_name": [
          "INFUMORPH 200"
        ],
        "generic_name": [
          "MORPHINE SULFATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-6039",
          "0641-6040"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INTRATHECAL"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "892652",
          "1731522",
          "1731998",
          "1731999"
        ],
        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
          "0641-6039-01",
          "0641-6040-01"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "X3P646A2J0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94208",
      "recalling_firm": "Hikma Pharmaceuticals USA Inc.",
      "address_1": "2 Esterbrook Ln",
      "address_2": "",
      "postal_code": "08003-4002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0392-2024",
      "product_description": "Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01",
      "product_quantity": "22,644 ampuls",
      "reason_for_recall": "The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.",
      "recall_initiation_date": "20240312",
      "center_classification_date": "20240321",
      "report_date": "20240327",
      "code_info": "Lot #:  052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024",
      "more_code_info": ""
    }
  ]
}