{
  "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": [
    {
      "country": "United States",
      "city": "Ocala",
      "address_1": "1210 SW 33rd Avenue",
      "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
      "address_2": "",
      "product_quantity": "110 units",
      "code_info": "Rx #'s:N0395099  N0389078  N0389083  N0389084  N0389085  N0389086  N0389089  N0389090  N0389093  N0389095  N0389097  N0389099  N0389100  N0390325  N0390326  N0390328  N0390329  N0390331  N0390332  N0390333  N0390338  N0390377  N0390380  N0390382  N0390383  N0390385  N0390390  N0390393  N0392339  N0392343  N0392344  N0392345  N0392347  N0392349  N0392351  N0392353  N0392354  N0392355  N0392357  N0392360  N0392363  N0392364  N0392367  N0392368  N0392370  N0392372  N0392374  N0392375  N0397646  N0397796  N0397797  N0397798  N0397802  N0397803  N0397804  N0397805  N0397806  N0397807  N0397990  N0397993  N0397994  N0397996  N0397997  N0398016  N0398017  N0398019  N0398020  N0398021  N0396955  N0398306  N0405187  N0401002  N0396784  N0398527  N0400271  N0400917  N0407735  N0409318  N0398310  N0408255  N0399153  N0404847  N0398297  N0399447  N0403452  N0406065  N0409741  N0397353  N0398612  N0406345  N0408105  N0393498  N0395106  N0401234  N0402072  N0402652  N0406677  N0397637  N0400888  N0398823  N0399918  N0400676  N0404455  N0398592  N0409187  N0393520  N0394243  N0406426  N0407548  N0397583",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies",
      "state": "FL",
      "product_description": "FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML;  FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML,\t200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML,\t400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab",
      "recall_number": "D-1518-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "62416",
      "termination_date": "20140813",
      "more_code_info": "",
      "recall_initiation_date": "20120525",
      "postal_code": "34474-5138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}