{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lambertville",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA210733"
        ],
        "brand_name": [
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-860",
          "64380-861"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "312529",
          "628953"
        ],
        "spl_id": [
          "84a960f2-6210-4381-8ac1-0af036da5b6d"
        ],
        "spl_set_id": [
          "0224e5b3-3c49-4e6e-aa78-1abcc6969246"
        ],
        "package_ndc": [
          "64380-860-06",
          "64380-860-07",
          "64380-860-08",
          "64380-861-06",
          "64380-861-07",
          "64380-861-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364380861065"
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "86283",
      "recalling_firm": "Strides Inc.",
      "address_1": "201 S Main St Ste 3",
      "address_2": "N/A",
      "postal_code": "08530-1859",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "nationwide",
      "recall_number": "D-0001-2021",
      "product_description": "Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP  8mEq  (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816     NDC 64380-860-06",
      "product_quantity": "11,280 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20200824",
      "center_classification_date": "20201001",
      "termination_date": "20220111",
      "report_date": "20201007",
      "code_info": "7240675A; Exp. 12/31/2021"
    }
  ]
}