{
  "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"
        ],
        "upc": [
          "350111647015"
        ]
      },
      "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-1281-2014",
      "product_description": "Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 50111-647-01, UPC 3 50111-647-01 5.",
      "product_quantity": "72,356 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 #: 6A211158, 6A211159, 6A211163, Exp 11/15",
      "more_code_info": ""
    }
  ]
}