{
  "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": "Newtown",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA210510"
        ],
        "brand_name": [
          "ATOVAQUONE ORAL SUSPENSION"
        ],
        "generic_name": [
          "ATOVAQUONE"
        ],
        "manufacturer_name": [
          "KVK-Tech, Inc."
        ],
        "product_ndc": [
          "10702-223"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATOVAQUONE"
        ],
        "rxcui": [
          "308429"
        ],
        "spl_id": [
          "5462a6ca-39eb-3b07-e063-6394a90a9020"
        ],
        "spl_set_id": [
          "b31ff20a-c363-4be0-9bc0-3081c163b63c"
        ],
        "package_ndc": [
          "10702-223-21"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310702223219"
        ],
        "nui": [
          "N0000175482",
          "N0000175485"
        ],
        "pharm_class_epc": [
          "Antimalarial [EPC]",
          "Antiprotozoal [EPC]"
        ],
        "unii": [
          "Y883P1Z2LT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88220",
      "recalling_firm": "KVK-Tech, Inc.",
      "address_1": "110 Terry Dr",
      "address_2": "N/A",
      "postal_code": "18940-3427",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to one distributor who may have further distributed Nationwide in the USA.",
      "recall_number": "D-0772-2021",
      "product_description": "Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA  18940, NDC 10702-223-21.",
      "product_quantity": "1,692 bottles",
      "reason_for_recall": "Temperature abuse: the firm received customer complaints of unusual grittiness in the product.",
      "recall_initiation_date": "20210702",
      "center_classification_date": "20210826",
      "termination_date": "20220523",
      "report_date": "20210901",
      "code_info": "Batch # 16653A, 16654A, Exp 12/2022"
    }
  ]
}