{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA065064"
        ],
        "brand_name": [
          "AMOXICILLIN AND CLAVULANATE POTASSIUM"
        ],
        "generic_name": [
          "AMOXICILLIN AND CLAVULANATE POTASSIUM"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
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          "0781-1874",
          "0781-1852",
          "0781-6102",
          "0781-6104"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "AMOXICILLIN",
          "CLAVULANATE POTASSIUM"
        ],
        "rxcui": [
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          "562508",
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          "617423",
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        "spl_set_id": [
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        "package_ndc": [
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          "0781-1831-20",
          "0781-1831-13",
          "0781-1831-01",
          "0781-1852-20",
          "0781-1852-13",
          "0781-1852-01",
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          "0781-6104-46",
          "0781-6104-57",
          "0781-6104-52"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0307816102462",
          "0307811831206",
          "0307811874319",
          "0307811852201"
        ],
        "unii": [
          "Q42OMW3AT8",
          "804826J2HU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77117",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NY, OH",
      "recall_number": "D-0868-2017",
      "product_description": "Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ   NDC 0781-1831-20",
      "product_quantity": "4,464 bottles",
      "reason_for_recall": "Subpotent Drug; \u001cClavulanic Acid",
      "recall_initiation_date": "20170426",
      "center_classification_date": "20170526",
      "termination_date": "20190819",
      "report_date": "20170607",
      "code_info": "Lot FP8735, 8/2017",
      "more_code_info": ""
    }
  ]
}