{
  "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": [
          "c7833be1-34d9-43e4-8aff-966c14aa2798"
        ],
        "spl_set_id": [
          "31362045-201f-45f3-99f2-a5e322a0c30b"
        ],
        "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": "97425",
      "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": "AZ, IN, NJ",
      "recall_number": "D-0621-2025",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10",
      "product_quantity": "3,591 bottles",
      "reason_for_recall": "CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.",
      "recall_initiation_date": "20250808",
      "center_classification_date": "20250908",
      "report_date": "20250917",
      "code_info": "Lot 240927C, Exp 04/30/2027"
    }
  ]
}