{
  "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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
      "address_2": "",
      "product_quantity": "64 units",
      "code_info": "Rx #'s:  T0372867  T0387431  T0388104  T0389467    T0389651  T0389841  T0391671  T0394240    T0395182  T0395583  T0396607  T0397069  T0397176  T0398192  T0399822  T0399900  T0400079  T0400081  T0400293  T0400444  T0400658  T0400794  T0400806  T0400871  T0401635  T0401644  T0401957  T0402166  T0402388  T0402390  T0402553  T0402656  T0402943  T0403559  T0405372  T0405460  T0406116  T0406555  T0406565  T0406984  T0407064  T0407383  T0407394  T0407440  T0407793  T0408122  T0408306  T0408399  T0408744  T0409050  T0409093  T0409107  T0409169  T0409178  T0396714  T0394672    T0395926  T0394672  T0394672  T0398564  T0394672",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "TROCAR KIT, STERILE DISPOSABLE**  DEVICE\t1 KIT  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t1 PELLET  \t2 KIT  \t  \t  \t3 KIT  \t4 KIT  \t5 KITS  \t6 KIT  (7 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-1631-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "62443",
      "termination_date": "20140815",
      "more_code_info": "",
      "recall_initiation_date": "20120521",
      "postal_code": "34474-5138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}