{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Berlin",
      "state": "CT",
      "country": "United States",
      "classification": "Class III",
      "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": [
          "32327581-bdab-41ac-9adc-bf208e1c4e42"
        ],
        "spl_set_id": [
          "caef6f50-1571-4ec7-8f8c-42b924d323ee"
        ],
        "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": "72563",
      "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",
      "recall_number": "D-0181-2016",
      "product_description": "Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10",
      "product_quantity": "595 Bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle",
      "recall_initiation_date": "20151021",
      "center_classification_date": "20151110",
      "termination_date": "20151224",
      "report_date": "20151118",
      "code_info": "Lot #: 142391, Exp 10/2016"
    }
  ]
}