{
  "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": "Cherry Hill",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA206968"
        ],
        "brand_name": [
          "ACETAMINOPHEN"
        ],
        "generic_name": [
          "ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9386"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "483017"
        ],
        "spl_id": [
          "e5ea1bad-d98b-475c-be6b-1d6415e3edff"
        ],
        "spl_set_id": [
          "88c29438-3648-4b09-bd43-70ad7a35bcb5"
        ],
        "package_ndc": [
          "0143-9386-01",
          "0143-9386-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94934",
      "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": "OH and PR",
      "recall_number": "D-0635-2024",
      "product_description": "Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ  NDC 0143-9386-01",
      "product_quantity": "31,400 bags",
      "reason_for_recall": "Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)",
      "recall_initiation_date": "20240708",
      "center_classification_date": "20240816",
      "report_date": "20240828",
      "code_info": "Lot #24070381; Exp. 09/30/2025",
      "more_code_info": ""
    }
  ]
}