{
  "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": "311 units",
      "code_info": "Rx #'s:  0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 0403792 0404381 0404597 0404937 0405274 0405602 0405880 0405881 0405889 0406307 0406538 0406558 0407551 0410050 0410051 0410054 0410335 0403801 0404660 0405429 0406714 0404383 0404424 0404429 0404431 0408668 0404381 0405641 0403996 0404175 0404381 0404598 0404985 0405057 0405274 0405520 0405687 0406286 0406538 0406573 0406905 0407288 0408084 0408783 0408855 0410229 0410380 0404381 0409102 0404479 0405889 0404597 0404661 0404881 0405520 0405836 0405881 0406558 0405174 0404381 0406372 0407748 0405429 0403860 0403862 0404014 0404169 0404533 0404735 0405599 0405896 0406440 0406612 0406750 0407072 0407940 0408312 0408462 0408930 0409264 0410399 0404881 0405639 0405654 0405882 0405883 0406752 0407396 0404682 0408308 0404383 0404381 0404328 0406996 0409438 0404660 0404183 0404435 0405283 0405348 0406510 0406660 0407382 0407748 0407844 0409421 0409755 0404159 0405637 0405926 0406895 0407005 0405084 0405180 0409839 0405174 0404014 0404171 0404187 0404314 0404526 0405237 0405472 0405522 0405871 0405896 0407001 0408598 0408601 0408761 0408821 0410024 0403801 0404159 0406339 0406752 0404659 0407005 0405884 0405897 0403788 0404014 0404184 0404624 0406610 0408898 0406161 0404937 0408175 0406989 0404001 0404002 0406671 0404133 0404146 0404171 0404172 0404182 0404381 0404435 0404526 0404529 0404530 0404531 0404533 0404608 0404620 0404732 0404846 0404875 0404904 0404979 0405171 0405347 0405348 0405687 0405879 0405910 0406151 0406207 0406286 0406491 0406520 0406560 0406612 0406680 0406892 0407001 0407240 0407580 0407585 0408487 0409058 0409077 0409494 0409554 0409582 0409590 0409592 0409846 0409848 0410323 0406325 0406895 0395514 0404133 0404314 0406829 0395514 0353249 0395514 0404533 0404598 0404734 0404742 0405676 0405887 0406902 0407236 0407462 0407757 0407802 0408372 0408752 0408833 0404479 0404381 0404531 0404573 0405522 0405925 0404617 0405428 0408161 0405428 0405428 0399738 0408376 0408385 0406368 0405178 0404163 0409151 0405049 0406485 0405049 0408044 0405181 0406845 0389952 0404159 0404163 0406848 0404833 0408322 0404829 0408324",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "WATER BACT STERILE - (25X30ML)***  INJECTABLE\t30 ML  \t750 MLS;  WATER STERILE - USP (25X10ML)*  INJECTABLE\t10 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t10 MLS  \t  \t100 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t100 MLS  \t  \t  \t  \t1000 ML  \t  \t  \t  \t  \t  \t  \t110 ML  \t  \t120 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t130 ML  \t  \t130 MLS  \t150   \t150 ML  \t  \t  \t  \t  \t  \t  \t150 MLS  \t160 ML  \t  \t  \t160 MLS  \t20   \t  \t20 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t200 ML  \t  \t  \t  \t  \t  \t  \t  \t200 MLS  \t  \t2000 ML  \t230 ML  \t240 ML  \t  \t250 ML  \t250 MLS  \t30 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t30 MLS  \t  \t  \t  \t  \t300   \t300 ML  \t  \t  \t  \t300 MLS  \t  \t40 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t40 MLS  \t  \t400 ML  \t  \t400 MLS  \t  \t50   \t  \t  \t50 ML  \t  \t  \t  \t  \t  \t50 MLS  \t500 ML  \t  \t500 MLS  \t60   \t  \t  \t60 ML  \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  \t  \t60 MLS  \t  \t6800 ML  \t70 ML  \t  \t  \t7240 ML  \t7500 ML  \t  \t  \t80 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t80 MLS  \t90 ML;  \t  \t  \t  WATER STERILE - USP (25X20ML)**  INJECTABLE\t1000 MLS  \t200 ML  \t200 MLS  \t  \t300 MLS  \t400 MLS  \t500 ML  \t60   \t60 ML  \t600 20  \t600 ML;  WATER STERILE - USP (25X50ML)**  INJECTABLE\t1000 ML  \t  \t  \t1150 ML  \t1250 MLS  \t1350 ML  \t150 MLS  \t2500 ML  \t300 ML  \t50 ML  \t  \t  \t500 ML  \t500 MLS  \t600   \t600 ML  \t600 MLS  (72 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-1643-2012",
      "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"
    }
  ]
}