{
  "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": [
    {
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      "city": "Berlin",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203088"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
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          "DULOXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
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        ],
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          "51991-747",
          "51991-748",
          "51991-750"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
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        ],
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          "596930",
          "596934",
          "616402"
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          "51991-746-90",
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          "51991-747-90",
          "51991-747-10",
          "51991-748-33",
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          "51991-750-90",
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        ],
        "is_original_packager": [
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        "unii": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "96707",
      "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": "US Nationwide.",
      "recall_number": "D-0387-2025",
      "product_description": "Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10",
      "product_quantity": "16,473 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.",
      "recall_initiation_date": "20250414",
      "center_classification_date": "20250422",
      "report_date": "20250430",
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    }
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}