{
  "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": "70976",
      "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",
      "recall_number": "D-0970-2015",
      "product_description": "Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01",
      "product_quantity": "",
      "reason_for_recall": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.",
      "recall_initiation_date": "20150413",
      "center_classification_date": "20150427",
      "termination_date": "20161027",
      "report_date": "20150506",
      "code_info": "Lot #: 6A207012, Exp 7/2015.",
      "more_code_info": ""
    }
  ]
}