{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076557"
        ],
        "brand_name": [
          "KIRKLAND SIGNATURE ALLERCLEAR D 24 HR"
        ],
        "generic_name": [
          "LORATADINE AND PSEUDOEPHEDRINE SULFATE"
        ],
        "manufacturer_name": [
          "Kirkland-COSTCO WHOLESALE COMPANY"
        ],
        "product_ndc": [
          "63981-724"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE",
          "PSEUDOEPHEDRINE SULFATE"
        ],
        "rxcui": [
          "1117562",
          "1369756"
        ],
        "spl_id": [
          "ebc90414-74b9-4186-99af-b1e655f177eb"
        ],
        "spl_set_id": [
          "b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6"
        ],
        "package_ndc": [
          "63981-724-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN",
          "Y9DL7QPE6B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88806",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0069-2022",
      "product_description": "AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15",
      "product_quantity": "46,584 blister packs",
      "reason_for_recall": "Failed Moisture Limits",
      "recall_initiation_date": "20211012",
      "center_classification_date": "20211026",
      "termination_date": "20230831",
      "report_date": "20211103",
      "code_info": "AC09723, Exo, Date 11/2022"
    }
  ]
}