{
  "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": "24 units",
      "code_info": "Rx #'s:  0395804      0395804    0404876    0405488    0404876    0403179    0403991    0407590      0407590    0394748    0394749    0403382    0405156    0401795    0401795    0400457    0400944    0392902    0406332    0398643    0405500    0397467",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "SODIUM BICARBONATE 4% INJECTABLE\t10 ML  \t  \t5 ML;  SODIUM BICARBONATE 8.4% INJECTABLE\t150 ML  \t50 ML  \t5000 ML;  SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE\t100 MLS  \t250 ML;  SODIUM BICARBONATE, MDV 8.4% INJECTABLE\t100 ML  \t  \t150 ML  \t200 ML;  \t  SODIUM CHLORIDE  0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE\t25 VIAL  \t40 ML;  SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION\t1000 ML  \t2500 ML;  SODIUM CHLORIDE 0.9%  BACTERIOSTATIC ** 0.9% INJECTABLE\t30 MLS  \t750 ML;  SODIUM CHLORIDE 0.9%  IRRIGATION (24X250ML)** 0.9% SOLUTION\t250 ML;  SODIUM CHLORIDE 0.9%, 100ML I.V. BAG** 0.9% INJECTABLE\t100 ML;  SODIUM TETRADECYL SO4 3% INJECTABLE\t20 ML;  \t  SODIUM TETRADECYL SULFATE  0.2 % INJECTABLE\t30 ML  (20 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-1618-2012",
      "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"
    }
  ]
}