{
  "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": "Ongoing",
      "city": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077824"
        ],
        "brand_name": [
          "RANITIDINE"
        ],
        "generic_name": [
          "RANITIDINE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals of New York LLC"
        ],
        "product_ndc": [
          "53746-253",
          "53746-254"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RANITIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "198191",
          "198193"
        ],
        "spl_id": [
          "8625e9c6-6542-43d2-a657-34161884a7d0"
        ],
        "spl_set_id": [
          "b38a3332-5c54-453f-aeb7-070f830955c2"
        ],
        "package_ndc": [
          "53746-253-60",
          "53746-253-01",
          "53746-253-18",
          "53746-253-05",
          "53746-253-10",
          "53746-254-30",
          "53746-254-01",
          "53746-254-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0353746254016",
          "0353746253019"
        ],
        "unii": [
          "BK76465IHM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "84353",
      "recalling_firm": "Amneal Pharmaceuticals, Inc.",
      "address_1": "50 Horseblock Rd",
      "address_2": "N/A",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-0616-2020",
      "product_description": "Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API",
      "recall_initiation_date": "20191122",
      "center_classification_date": "20191209",
      "report_date": "20191218",
      "code_info": "HB04118A 2/2020  HB04218A 2/2020  HB04318A 2/2020  HB04418A 2/2020  HF13518A 6/2020  HF13618A 6/2020  HF13718A 6/2020  HF13818A 6/2020  HK02818A 9/2020  HK02918A 9/2020  HK03018A 9/2020  HK03118A 9/2020  HL08418A 11/2020  HL08518A 11/2020  HL08618A 11/2020  HL08718A 11/2020  HB01419A 1/2021  HB05619A 1/2021  HB05719A 1/2021  HB05819A 1/2021  HB05919A 1/2021  HB06019A 1/2021  HB06119A 1/2021",
      "more_code_info": ""
    }
  ]
}