{
  "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": "Irving",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213175"
        ],
        "brand_name": [
          "GEMCITABINE"
        ],
        "generic_name": [
          "GEMCITABINE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9340",
          "0143-9341",
          "0143-9342"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GEMCITABINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1720960",
          "1720975",
          "1720977"
        ],
        "spl_id": [
          "e9bd951d-0a47-409c-aa7c-2df9157d94e2"
        ],
        "spl_set_id": [
          "d80176fe-3e8b-48be-87c2-9c603013b3fa"
        ],
        "package_ndc": [
          "0143-9340-01",
          "0143-9341-01",
          "0143-9342-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "U347PV74IL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99262",
      "recalling_firm": "McKesson",
      "address_1": "6555 State Highway 161",
      "address_2": "N/A",
      "postal_code": "75039-2402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0714-2026",
      "product_description": "Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922.  NDC: 0143-9341-01",
      "product_quantity": "74  units",
      "reason_for_recall": "Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.",
      "recall_initiation_date": "20260610",
      "center_classification_date": "20260721",
      "report_date": "20260708",
      "code_info": "Lot #: CB0046, Exp. Date 06/2027"
    }
  ]
}