{
  "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": "53 units",
      "code_info": "Rx #'s:    0385046    0406983    0367360          0384324    0406983    0397099    0398852    0398855    0398856    0405772    0406983    0390146      0398705    0398707    0398709    0398717    0398721    0398732    0377099    0377104    0384258    0384317    0390142      0390148      0390154    0390160    0390163    0390146    0404961    0369755    0377099    0377101    0377104      0380763    0384258    0384323    0384324    0390142    0390148    0391675    0400729    0405530    0377099    0377101    0377104    0380763",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE\t1 VIAL  \t1 VIALS  \t12 VIAL  \t  \t  \t  \t12 VIALS  \t2 VIALS  \t3 VIALS  \t4 VIAL  \t  \t  \t4 VIALS  \t  \t5 VIAL  \t  \t  \t  \t  \t  \t  \t  \t5 VIALS  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t6 VIAL  \t  \t6 VIALS  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t8 VIALS  (13 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-1624-2012",
      "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"
    }
  ]
}