{
  "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": [
          "LORATADINE AND PSEUDOEPHEDRINE SULFATE"
        ],
        "generic_name": [
          "LORATADINE AND PSEUDOEPHEDRINE SULFATE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-5833"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE",
          "PSEUDOEPHEDRINE SULFATE"
        ],
        "rxcui": [
          "1117562"
        ],
        "spl_id": [
          "3e4ab498-9f9e-bd3b-e063-6294a90a9b9c"
        ],
        "spl_set_id": [
          "2620a150-4a2c-4fa2-a0e4-6aafe9e496c3"
        ],
        "package_ndc": [
          "0904-5833-15",
          "0904-5833-48"
        ],
        "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-0068-2022",
      "product_description": "Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15",
      "product_quantity": "22,752 blister packs",
      "reason_for_recall": "Failed Moisture Limits",
      "recall_initiation_date": "20211012",
      "center_classification_date": "20211026",
      "termination_date": "20230831",
      "report_date": "20211103",
      "code_info": "Lot #: AC14635, Exp. Date 12/2022"
    }
  ]
}