{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Yardley",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206813"
        ],
        "brand_name": [
          "POTASSIUM CITRATE"
        ],
        "generic_name": [
          "POTASSIUM CITRATE"
        ],
        "manufacturer_name": [
          "Strides Pharma Inc."
        ],
        "product_ndc": [
          "42543-406",
          "42543-407",
          "42543-408"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM CITRATE"
        ],
        "rxcui": [
          "199376",
          "199381",
          "898490"
        ],
        "spl_id": [
          "67ba2683-6fb5-429e-ab39-6f004ac33f1b"
        ],
        "spl_set_id": [
          "5f38b02c-703c-4fc2-b833-654e41bd617f"
        ],
        "package_ndc": [
          "42543-406-01",
          "42543-407-01",
          "42543-408-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "EE90ONI6FF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80553",
      "recalling_firm": "VENSUN PHARMACEUTICALS INC",
      "address_1": "790 Township Line Rd",
      "address_2": "N/A",
      "postal_code": "19067-4248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Within the United States and Puerto Rico.",
      "recall_number": "D-1018-2018",
      "product_description": "Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.",
      "product_quantity": "3,683 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Tablet breakage",
      "recall_initiation_date": "20180718",
      "center_classification_date": "20180727",
      "termination_date": "20190416",
      "report_date": "20180808",
      "code_info": "Lot #: 9570012, Exp. June-2019"
    }
  ]
}