{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA208040"
        ],
        "brand_name": [
          "DABIGATRAN ETEXILATE"
        ],
        "generic_name": [
          "DABIGATRAN ETEXILATE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-7253",
          "0904-7254",
          "0904-7255"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DABIGATRAN ETEXILATE MESYLATE"
        ],
        "rxcui": [
          "1037045",
          "1037179",
          "1723476"
        ],
        "spl_id": [
          "869fd2f3-9357-4148-8b64-0cca96dd5f75"
        ],
        "spl_set_id": [
          "b76b79ce-b7dd-4390-b40e-71ae6c477d10"
        ],
        "package_ndc": [
          "0904-7253-35",
          "0904-7253-04",
          "0904-7253-68",
          "0904-7254-35",
          "0904-7254-68",
          "0904-7255-35",
          "0904-7255-10",
          "0904-7255-68"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0309047253043",
          "0309047255108"
        ],
        "unii": [
          "SC7NUW5IIT"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99330",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "135 Us Highway 202 206 Ste 15",
      "address_2": "N/A",
      "postal_code": "07921-2608",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0736-2026",
      "product_description": "Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.",
      "product_quantity": "2,717 cartons",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.",
      "recall_initiation_date": "20260630",
      "center_classification_date": "20260804",
      "report_date": "20260729",
      "code_info": "Lot: 25141584, Exp 4/30/2027."
    }
  ]
}