{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Ambarnath",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208708"
        ],
        "brand_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Advagen Pharma Limited"
        ],
        "product_ndc": [
          "72888-008",
          "72888-162",
          "72888-080",
          "72888-163"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAMADOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "835603",
          "2179635",
          "2670390",
          "2692878"
        ],
        "spl_id": [
          "47c74a4e-51f2-e294-e063-6394a90aa70b"
        ],
        "spl_set_id": [
          "93b12089-3a0f-4b57-abb1-2429cf31995d"
        ],
        "package_ndc": [
          "72888-162-30",
          "72888-162-01",
          "72888-162-05",
          "72888-162-00",
          "72888-080-01",
          "72888-080-05",
          "72888-080-00",
          "72888-163-30",
          "72888-163-01",
          "72888-163-05",
          "72888-163-00",
          "72888-008-01",
          "72888-008-05",
          "72888-008-00"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0372888163000",
          "0372888008059",
          "0372888080055",
          "0372888163307",
          "0372888008011",
          "0372888008004",
          "0372888162300",
          "0372888163055",
          "0372888080017",
          "0372888162003",
          "0372888162010",
          "0372888080000",
          "0372888163017",
          "0372888162058"
        ],
        "unii": [
          "9N7R477WCK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94467",
      "recalling_firm": "Rubicon Research Private Limited",
      "address_1": "4 & K30 5 Plot No K - 30",
      "address_2": "District",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0487-2024",
      "product_description": "traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00",
      "product_quantity": "2,592 1000-count Bottles",
      "reason_for_recall": "Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol",
      "recall_initiation_date": "20240426",
      "center_classification_date": "20240507",
      "report_date": "20240515",
      "code_info": "Lot #: 230774Hl, Exp 4/30/2026"
    }
  ]
}