{
  "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": "15 units",
      "code_info": "Rx #'s:  0397942              0397942    0395256    0395256    0387634        0397219    0400108    0387634    0370170    0370170            0370170    0389690        0389690",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE\t24 ML  \t  \t  \t  \t  \t  \t6 ML;  LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE\t10 ML  \t40 ML;  LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE\t100 ML  \t  \t  \t1200 ML  \t300 ML  \t80 ML;  LIDOCAINE/EPINEPHRINE  1%/0.00025% OPHTHALMIC\t30 ML  \t60 ML  \t  \t  \t  \t  \t90 ML;  LIDOCAINE/EPINEPHRINE, P.F. (FOR DILUTION WITH BSS+) 1.71%/0.057% OPHTHALMIC\t14 ML  \t  \t  \t7 ML  (8 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-1560-2012",
      "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"
    }
  ]
}