{
  "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": {
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        ],
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        ],
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        ],
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          "51991-747",
          "51991-748",
          "51991-750"
        ],
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        ],
        "route": [
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        ],
        "substance_name": [
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        ],
        "rxcui": [
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          "596930",
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          "616402"
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          "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",
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        "is_original_packager": [
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        "unii": [
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      },
      "product_type": "Drugs",
      "event_id": "96582",
      "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": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0308-2025",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.",
      "product_quantity": "14,863 bottles",
      "reason_for_recall": "CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.",
      "recall_initiation_date": "20250326",
      "center_classification_date": "20250401",
      "report_date": "20250409",
      "code_info": "Lot 240909C, Exp Date 03/31/2027",
      "more_code_info": ""
    }
  ]
}