{
  "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": "13 units",
      "code_info": "Rx #'s:    0398243    0394272      0383374    0396251      0365041      0409704    0406772    0406773    0399065    0384313",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC\t15 ML  \t3 ML  \t  \t7 ML;  \t  \t  TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC\t30 MLS  \t  \t5 MLS;  TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE\t100 ML  \t150 ML  \t50 MLS;  TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB\t70 ML  (9 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-1627-2012",
      "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"
    }
  ]
}