{
  "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": "171 units",
      "code_info": "Rx #'s:  0402163    0401103    0361246    0374339    0400819    0401878    0376767    0357627      0358558    0385752    0387435                0388683    0398782          0389025    0389135    0394537    0400051    0410208    0389025                0388231    0391057      0405031    0393211    0393211    0388792      0384288            0407535    0378398    0378398          0377517        0378503    0378504    0380549      0381687    0383319    0385206      0390165    0390166    0390930    0392241    0396501      0396675    0397835    0398312    0398392      0398889    0402538    0402842    0405320    0408916    0378060            0378502    0385165              0399334    0399337    0399340    0399345    0399348    0408326    0405172    0396619    0393974    0378077    0380549    0385218      0399333    0399346    0399349    0399351    0399353    0399354    0399356    0399358    0399361    0399362    0392241    0405640    0402538    0396501    0377276    0377517    0377857    0378077    0379493    0380295    0380549    0380551    0381687    0385218    0387271    0387274    0387280    0387282    0389068    0390166    0390930    0391460    0391463    0391466    0391469    0391576        0391881    0392180      0392182      0392184      0395103      0395519    0396501      0404869    0409343    0409489    0409490    0409492    0410150    0410384    0367933    0395652      0396783        0408328    0402535",
      "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": "GENTAMICIN  40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML;  GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER  0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML; GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML; GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML; GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML; GENTAMICIN IRRIGATION 480MG/LITER SOLUTION 1000 ML, 2000 ML; GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE\t100 ML, 100 MLS, 100 VIAL, 12 ML, 14 ML, 150 ML, 200 ML, 25, 40 ML, 50 ML, 50 MLS, 50 VIALS (26 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-1528-2012",
      "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"
    }
  ]
}