{
  "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": "Terminated",
      "city": "Berlin",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203088"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
        "generic_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Breckenridge Pharmaceutical, Inc."
        ],
        "product_ndc": [
          "51991-746",
          "51991-747",
          "51991-748",
          "51991-750"
        ],
        "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": [
          "51991-746-06",
          "51991-746-90",
          "51991-746-05",
          "51991-747-33",
          "51991-747-90",
          "51991-747-10",
          "51991-748-33",
          "51991-748-90",
          "51991-748-10",
          "51991-750-33",
          "51991-750-90",
          "51991-750-05",
          "51991-750-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94611",
      "recalling_firm": "Breckenridge Pharmaceutical, Inc",
      "address_1": "15 Massirio Dr Ste 201",
      "address_2": "N/A",
      "postal_code": "06037-2352",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0562-2024",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle,  Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90",
      "product_quantity": "165,678, 90-count bottles",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit",
      "recall_initiation_date": "20240517",
      "center_classification_date": "20240620",
      "termination_date": "20260407",
      "report_date": "20240626",
      "code_info": "Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025"
    }
  ]
}