{
  "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-0615-2020",
      "product_description": "Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.",
      "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": "HB03718A 3/2020  HB03818A 3/2020  HB03918A 3/2020  HB04018A 3/2020  HC01618A 3/2020  HC14618A 5/2020  HC14718A 5/2020  HC14818A 5/2020  HC14918A 5/2020  HC15018A 5/2020  HK02318A 9/2020  HK02418A 9/2020  HK02518A 9/2020  HK02618A 9/2020  HD03119A 3/2021  HD03219A 3/2021  HE03119A 4/2021  HE03219A 4/2021",
      "more_code_info": ""
    }
  ]
}