{
  "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": "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": "94483",
      "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-0484-2024",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, 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": "281,554/90 count bottles",
      "reason_for_recall": "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit",
      "recall_initiation_date": "20240429",
      "center_classification_date": "20240504",
      "report_date": "20240515",
      "code_info": "230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp.  Dec 2024 220363: Exp. Feb 2025"
    }
  ]
}