{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA201695"
        ],
        "brand_name": [
          "FAMOTIDINE"
        ],
        "generic_name": [
          "FAMOTIDINE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-500"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "310274"
        ],
        "spl_id": [
          "82462011-668a-4fbd-9653-48049901eacc"
        ],
        "spl_set_id": [
          "a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8"
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        "package_ndc": [
          "43386-500-11"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0343386500116"
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68722",
      "recalling_firm": "Novel Laboratories, Inc.",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1484-2014",
      "product_description": "Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873.  Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.",
      "product_quantity": "25,776 containers",
      "reason_for_recall": "Failed Impurity/Degradation Specification; 12-month stability time point",
      "recall_initiation_date": "20140620",
      "center_classification_date": "20140822",
      "termination_date": "20150629",
      "report_date": "20140903",
      "code_info": "Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016."
    }
  ]
}