{
  "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": "Berkeley Heights",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203088"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
        "generic_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Quallent Pharmaceuticals Health, LLC"
        ],
        "product_ndc": [
          "82009-029",
          "82009-030",
          "82009-032",
          "82009-031"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "596926",
          "596930",
          "596934",
          "616402"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "82009-029-05",
          "82009-030-10",
          "82009-032-10",
          "82009-031-30",
          "82009-031-90"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97336",
      "recalling_firm": "Breckenridge Pharmaceutical, Inc.",
      "address_1": "200 Connell Dr Ste 4200",
      "address_2": "N/A",
      "postal_code": "07922-2805",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ, AZ, IN",
      "recall_number": "D-0580-2025",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain.  Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC  82009-032-10",
      "product_quantity": "1,856 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.",
      "recall_initiation_date": "20250725",
      "center_classification_date": "20250812",
      "report_date": "20250820",
      "code_info": "Lot 240539C, Exp 1/31/2027",
      "more_code_info": ""
    }
  ]
}