{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA214313"
        ],
        "brand_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "generic_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0040",
          "0338-0112",
          "0338-0108",
          "0338-0116",
          "0338-0042",
          "0338-0128"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
          "2475337",
          "2475340",
          "2619579"
        ],
        "spl_id": [
          "b40627c0-67bf-4740-9d21-83054aa6afd9"
        ],
        "spl_set_id": [
          "6363e9b4-29df-4553-904d-a563e5adda6e"
        ],
        "package_ndc": [
          "0338-0112-20",
          "0338-0108-20",
          "0338-0116-20",
          "0338-0040-20",
          "0338-0042-20",
          "0338-0128-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IFY5PE3ZRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93843",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0336-2024",
      "product_description": "Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015.  Made in Ireland.  NDC:  0338-0108-20",
      "product_quantity": "13,000 bags",
      "reason_for_recall": "Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.",
      "recall_initiation_date": "20240123",
      "center_classification_date": "20240216",
      "report_date": "20240228",
      "code_info": "Lot 23I21G64; Exp. 07/31/2024"
    }
  ]
}