{
  "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": "Completed",
      "city": "Basking Ridge",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206937"
        ],
        "brand_name": [
          "FLUOXETINE"
        ],
        "generic_name": [
          "FLUOXETINE"
        ],
        "manufacturer_name": [
          "Torrent Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "13668-443",
          "13668-473"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "2532163"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "13668-443-10",
          "13668-443-01",
          "13668-443-30",
          "13668-443-91",
          "13668-473-10",
          "13668-473-74",
          "13668-473-30",
          "13668-473-01",
          "13668-473-91",
          "13668-473-70"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0313668443301",
          "0313668473308"
        ],
        "unii": [
          "I9W7N6B1KJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96983",
      "recalling_firm": "Torrent Pharma Inc.",
      "address_1": "106 Allen Rd Ste 305",
      "address_2": "N/A",
      "postal_code": "07920-3851",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0456-2025",
      "product_description": "Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)",
      "product_quantity": "972 Cartons",
      "reason_for_recall": "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.",
      "recall_initiation_date": "20250527",
      "center_classification_date": "20250602",
      "report_date": "20250611",
      "code_info": "Lot# BDX6K001; Exp. Date: 06/30/2025"
    }
  ]
}