{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090162"
        ],
        "brand_name": [
          "TOPIRAMATE"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-115",
          "29300-116",
          "29300-117",
          "29300-118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "151226",
          "199888",
          "199889",
          "199890"
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        "spl_id": [
          "b609e53c-2d69-4437-b2a1-9f322208eb27"
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        "spl_set_id": [
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        "package_ndc": [
          "29300-115-16",
          "29300-115-01",
          "29300-115-05",
          "29300-115-10",
          "29300-116-16",
          "29300-116-01",
          "29300-116-05",
          "29300-116-10",
          "29300-117-16",
          "29300-117-01",
          "29300-117-05",
          "29300-117-10",
          "29300-118-16",
          "29300-118-01",
          "29300-118-05",
          "29300-118-10"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0329300118162"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88891",
      "recalling_firm": "UNICHEM PHARMACEUTICALS USA INC",
      "address_1": "1 Tower Center Blvd Ste 2200",
      "address_2": "",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0255-2022",
      "product_description": "Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India.  Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.",
      "product_quantity": "1284 bottles",
      "reason_for_recall": "Discoloration",
      "recall_initiation_date": "20211025",
      "center_classification_date": "20211119",
      "termination_date": "20221012",
      "report_date": "20211201",
      "code_info": "Lot #: ZTPM20044, Exp. Date 09/30/2022",
      "more_code_info": ""
    }
  ]
}