{
  "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": "Terminated",
      "city": "Whippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA210861"
        ],
        "brand_name": [
          "VITRAKVI"
        ],
        "generic_name": [
          "LAROTRECTINIB"
        ],
        "manufacturer_name": [
          "Bayer HealthCare Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "50419-390",
          "50419-391",
          "50419-392",
          "50419-393"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LAROTRECTINIB"
        ],
        "rxcui": [
          "2105633",
          "2105645",
          "2105649",
          "2105653",
          "2105655",
          "2105657"
        ],
        "spl_id": [
          "0e3ba6e7-af8d-4840-9409-a537a09e1263"
        ],
        "spl_set_id": [
          "0c8ca614-58b2-4aa4-83d3-0387a8f782fd"
        ],
        "package_ndc": [
          "50419-390-01",
          "50419-391-01",
          "50419-392-01",
          "50419-393-02",
          "50419-393-03"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175605",
          "N0000193859"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Tropomyosin Receptor Kinases Inhibitors [MoA]"
        ],
        "unii": [
          "PF9462I9HX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93391",
      "recalling_firm": "Bayer Healthcare Pharmaceuticals Inc.",
      "address_1": "100 Bayer Blvd",
      "address_2": "",
      "postal_code": "07981-1544",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.",
      "recall_number": "D-0145-2024",
      "product_description": "VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01",
      "product_quantity": "192 bottles",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing",
      "recall_initiation_date": "20231106",
      "center_classification_date": "20231207",
      "termination_date": "20240529",
      "report_date": "20231206",
      "code_info": "Lot# 2114228, EXP. 02/29/2024",
      "more_code_info": ""
    }
  ]
}