{
  "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": "134 units",
      "code_info": "Rx #'s:  0392321    0394025    0388514    0401919    0350642    0394025      0388514      0394025    0388514      0390732    0390733    0390734    0390735    0390736    0390737    0390738    0380350    0368327    0374556        0367241    0389528    0387672    0387673    0388017    0388019    0388022    0388506    0388512    0388515    0392608    0392615    0392616    0392619    0392621    0396198    0396215    0396216    0396229    0396231    0399438    0399439    0399442    0399445    0403009    0403010    0403011    0403012    0403013      0406259    0406260    0406262    0406344    0407979    0407983    0407994    0407995    0407997    0389528    0380350    0391097    0391097    0391097    0394711    0394711    0396280    0396282    0401229    0401451      0403261    0403264    0403265    0403266    0406344    0367241            0391097      0360638    0360913    0370332      0374556      0367241    0368572    0374556    0390415    0396119    0381037    0381037    0409349    0381037    0407487    0369244        0398000    0400203    0369244    0401228    0365406    0381433    0382639    0397201    0408640    0398000    0366257    0366257    0381433    0387899    0408486    0381433    0387899    0397201    0401228    0382639    0403456      0358087    0394872    0401833    0403472    0392320    0360357",
      "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": "INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT,  50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS)  \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  \t2 VIAL  \t20 KIT  \t22 KITS  \t25 KITS  \t3 KITS  \t3 VIALS  \t4 VIALS  \t5 KIT  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t50 KIT  \t  \t  \t  \t  \t50 KITS  \t  \t6 KIT  \t  \t  \t  \t  \t  \t60 KIT  \t8 KIT  \t  INDOCYANINE GREEN - KIT 25MG INJECTABLE\t1 KIT  \t6 KIT  INDOCYANINE GREEN - KIT 30MG INJECTABLE\t10 KIT  \t14 KIT  \t25 KIT  \t5 KIT  INDOCYANINE GREEN - KIT 5MG INJECTABLE\t1 KIT  \t10 KIT  \t  \t  \t  \t  \t12 KIT  \t15 KIT  \t15 VIAL  \t2 KIT  \t  \t  \t20 KIT  \t25 KIT  \t3 KIT  \t4 KIT  \t  \t  \t  \t5 KIT  \t  \t  \t  \t6 KIT  \t  \t  \t8 KIT  INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL\t1 VIAL  INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL\t2 VIAL  \t5 VIAL  INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL\t1 VIAL  \t2 KIT",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab",
      "recall_number": "D-1546-2012",
      "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"
    }
  ]
}