{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075294"
        ],
        "brand_name": [
          "RANITIDINE"
        ],
        "generic_name": [
          "RANITIDINE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-131"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RANITIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "312773"
        ],
        "spl_id": [
          "210e3c0b-be93-aa50-550d-e383e7d5f19e"
        ],
        "spl_set_id": [
          "12a38e29-130c-6d41-1753-acccb0b41efe"
        ],
        "package_ndc": [
          "55111-131-30",
          "55111-131-60",
          "55111-131-80",
          "55111-131-90",
          "55111-131-04",
          "55111-131-37",
          "55111-131-79",
          "55111-131-14",
          "55111-131-81",
          "55111-131-45"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BK76465IHM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "83908",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to major distributors throughout the United States who may have further distributed the product.",
      "recall_number": "D-0181-2020",
      "product_description": "Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: Presence of NDMA impurity detected in product.",
      "recall_initiation_date": "20191001",
      "center_classification_date": "20191105",
      "report_date": "20191113",
      "code_info": "Batch Numbers:  All lots within expiry."
    }
  ]
}