{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA202868"
        ],
        "brand_name": [
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "BluePoint Laboratories"
        ],
        "product_ndc": [
          "68001-396"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "312504"
        ],
        "spl_id": [
          "431ff2ef-567c-4b60-af43-f4da61febaad"
        ],
        "spl_set_id": [
          "431ff2ef-567c-4b60-af43-f4da61febaad"
        ],
        "package_ndc": [
          "68001-396-00",
          "68001-396-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94946",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0619-2024",
      "product_description": "Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India.  Distributed for: BluePoint Laboratories.",
      "product_quantity": "61,231 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20240625",
      "center_classification_date": "20240728",
      "report_date": "20240807",
      "code_info": "[100 count bottles]:   Lot 17221738, Exp 07/31/2024;  Lot 17222494, Exp 10/31/2024;  Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025;   [500 count bottles]:    Lot 17221823, Lot 17221830, Exp 07/31/2024;  Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820, Exp 02/28/2025; Lot 17230825, Lot 17230833, Lot 17230840, Exp 03/31/2025; Lot 17231537, Lot 17231540, Lot 17231719, Lot 17231737, Exp 06/30/2025; Lot 17232111, Lot 17232164, Exp 09/30/2025"
    }
  ]
}