{
  "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": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA202868"
        ],
        "brand_name": [
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-357"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "312504"
        ],
        "spl_id": [
          "b0251572-aa7f-434a-a7ff-33ccbc37dfaf"
        ],
        "spl_set_id": [
          "5b054142-7372-4641-be27-dca630a97ad9"
        ],
        "package_ndc": [
          "68462-357-90",
          "68462-357-01",
          "68462-357-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94715",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0605-2024",
      "product_description": "Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05",
      "product_quantity": "36,630 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20240530",
      "center_classification_date": "20240717",
      "report_date": "20240724",
      "code_info": "Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;",
      "more_code_info": ""
    }
  ]
}