{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Camarillo",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203088"
        ],
        "brand_name": [
          "DULOXETINE"
        ],
        "generic_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Golden State Medical Supply, Inc."
        ],
        "product_ndc": [
          "60429-164",
          "60429-165",
          "60429-166"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DULOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "596926",
          "596930",
          "596934"
        ],
        "spl_id": [
          "3a8cefd0-9db7-8cd0-e063-6394a90a5996"
        ],
        "spl_set_id": [
          "f535fcd2-a50a-4423-85d9-705fd2d9a470"
        ],
        "package_ndc": [
          "60429-164-60",
          "60429-165-30",
          "60429-165-90",
          "60429-166-30",
          "60429-166-10"
        ],
        "original_packager_product_ndc": [
          "51991-746",
          "51991-747",
          "51991-748"
        ],
        "unii": [
          "9044SC542W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94639",
      "recalling_firm": "Golden State Medical Supply Inc.",
      "address_1": "5187 Camino Ruiz",
      "address_2": "",
      "postal_code": "93012-8601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-0568-2024",
      "product_description": "Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.",
      "product_quantity": "21,655 (30 count bottle), 34,149 (90 count bottle)",
      "reason_for_recall": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.",
      "recall_initiation_date": "20240513",
      "center_classification_date": "20240625",
      "termination_date": "20250320",
      "report_date": "20240703",
      "code_info": "Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025",
      "more_code_info": ""
    }
  ]
}