{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Berkeley Heights",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
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        ],
        "generic_name": [
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        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "82009-030",
          "82009-032",
          "82009-031"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
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        ],
        "rxcui": [
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          "596930",
          "596934",
          "616402"
        ],
        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "82009-030-10",
          "82009-032-10",
          "82009-031-30",
          "82009-031-90"
        ],
        "is_original_packager": [
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        ],
        "unii": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "98034",
      "recalling_firm": "Breckenridge Pharmaceutical, Inc.",
      "address_1": "200 Connell Dr Ste 4200",
      "address_2": "",
      "postal_code": "07922-2805",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0215-2026",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.",
      "product_quantity": "3397 bottles",
      "reason_for_recall": "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit",
      "recall_initiation_date": "20251124",
      "center_classification_date": "20251203",
      "report_date": "20251210",
      "code_info": "Lot #: 240947C, 240962C, Exp. Date 04/2027",
      "more_code_info": ""
    }
  ]
}