{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076805"
        ],
        "brand_name": [
          "CHILDRENS LORATADINE"
        ],
        "generic_name": [
          "LORATADINE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-2092"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORATADINE"
        ],
        "rxcui": [
          "692783"
        ],
        "spl_id": [
          "38f6a9dc-6612-4e51-e063-6294a90a8f2a"
        ],
        "spl_set_id": [
          "c4d05a9a-3765-4144-803e-462712bf3772"
        ],
        "package_ndc": [
          "51672-2092-4",
          "51672-2092-8",
          "51672-2092-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7AJO3BO7QN"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70183",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0383-2015",
      "product_description": "Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.",
      "product_quantity": "36,684 Bottles",
      "reason_for_recall": "Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.",
      "recall_initiation_date": "20141230",
      "center_classification_date": "20150205",
      "termination_date": "20180604",
      "report_date": "20150211",
      "code_info": "Lot #: A4105, Exp 12/2016"
    }
  ]
}