{
  "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": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022231"
        ],
        "brand_name": [
          "TERLIVAZ"
        ],
        "generic_name": [
          "TERLIPRESSIN"
        ],
        "manufacturer_name": [
          "Mallinckrodt Hospital Products Inc."
        ],
        "product_ndc": [
          "43825-200"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TERLIPRESSIN"
        ],
        "rxcui": [
          "2612431",
          "2612436"
        ],
        "spl_id": [
          "f838b29e-0369-4f88-8176-1c504ea76597"
        ],
        "spl_set_id": [
          "3a35b86c-f451-4fac-8499-43019e4da354"
        ],
        "package_ndc": [
          "43825-200-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000194045",
          "N0000194046"
        ],
        "pharm_class_epc": [
          "Vasopressin Receptor Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Vasopressin Receptor Agonists [MoA]"
        ],
        "unii": [
          "7Z5X49W53P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93945",
      "recalling_firm": "Mallinckrodt Hospital Products Inc.",
      "address_1": "440 Us Highway 22",
      "address_2": "Ste 302",
      "postal_code": "08807-2477",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-0341-2024",
      "product_description": "Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01",
      "product_quantity": "421 vials involved in this recall (2,448 vials distributed)",
      "reason_for_recall": "cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.",
      "recall_initiation_date": "20240206",
      "center_classification_date": "20240221",
      "report_date": "20240228",
      "code_info": "Lot #: 22TRP01-F2, Exp 6/30/2024"
    }
  ]
}