{
  "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": "Horsham",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076001"
        ],
        "brand_name": [
          "FLUOXETINE"
        ],
        "generic_name": [
          "FLUOXETINE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "50111-647",
          "50111-648"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUOXETINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "310384",
          "310385"
        ],
        "spl_id": [
          "424ed364-e023-472f-b113-673e9342a7f1"
        ],
        "spl_set_id": [
          "06d71a33-5578-4012-b11d-764f45bc1e6a"
        ],
        "package_ndc": [
          "50111-647-01",
          "50111-647-02",
          "50111-647-03",
          "50111-648-01",
          "50111-648-02",
          "50111-648-03",
          "50111-648-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "I9W7N6B1KJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67563",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "425 Privet Rd",
      "address_2": "",
      "postal_code": "19044-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1280-2014",
      "product_description": "Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960.",
      "product_quantity": "257904 bottles",
      "reason_for_recall": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.",
      "recall_initiation_date": "20140212",
      "center_classification_date": "20140428",
      "termination_date": "20141215",
      "report_date": "20140507",
      "code_info": "Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15",
      "more_code_info": ""
    }
  ]
}