{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
          "RANOLAZINE"
        ],
        "generic_name": [
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        "manufacturer_name": [
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        ],
        "product_ndc": [
          "27241-125",
          "27241-126"
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        "product_type": [
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        ],
        "route": [
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        "rxcui": [
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          "728231"
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        "spl_set_id": [
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          "27241-125-05",
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          "27241-126-05"
        ],
        "is_original_packager": [
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        "upc": [
          "0327241125027",
          "0327241126024"
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        "nui": [
          "N0000175427",
          "N0000190114",
          "N0000185503",
          "N0000182137",
          "N0000187061"
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        "pharm_class_epc": [
          "Anti-anginal [EPC]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]",
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "A6IEZ5M406"
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      },
      "product_type": "Drugs",
      "event_id": "99893",
      "recalling_firm": "Ajanta Pharma USA Inc",
      "address_1": "400 Crossing Blvd Ste 102",
      "address_2": "",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US.",
      "recall_number": "D-0010-2027",
      "product_description": "Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807.  NDC: 27241-126-02",
      "product_quantity": "",
      "reason_for_recall": "Failed Dissolution Specifications: below specification",
      "recall_initiation_date": "20260917",
      "center_classification_date": "20261006",
      "report_date": "20261007",
      "code_info": "Lot: DJ25134, Exp 11/30/2028",
      "more_code_info": ""
    }
  ]
}