{
  "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": "78 units",
      "code_info": "Rx #'s:  0391506      0387832      0379379                        0384684    0393073    0401183    0362996    0390985    0391304    0391536    0401641    0405794    0381389    0354014      0394430    0376201    0391434    0391655    0399075    0399950    0400595    0401944    0406909    0408906    0408911    0409594    0409904    0394430        0406648    0372200        0387977    0389172    0390806    0392300    0392584    0394307    0394757    0398054    0398203    0399720    0400786    0402244    0402746    0406118    0406497    0409911    0410108    0394860    0363347      0406812    0394712      0374379      0395812    0402219      0371817    0380501    0403485",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE\t10 ML  \t  \t200 ML  \t  \t30 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t50 ML;  METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE\t10 ML  \t  \t  \t  \t  \t  \t150 ML  \t180 ML  \t  \t  \t30 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t360 ML  \t  \t  \t4 ML  \t5 ML;  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/VIT B-12  0.8/1.6/1.6/0.0001/0.03% IN\t30 ML;  METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROMIUM CHLORIDE 0.8/1.6/1.6/0.0001/0.03% \t100 ML  \t  \t  \t30 ML  \t  \t80 ML;  \t  METHIONINE/INOSITOL/CHOLINE CHLORIDE/VIT B12 0.8%/1.6%/1.6%/1200MCG/ML INJECTABL\t30 ML;  METHIONINE/INOSITOL/CHOLINE CL/B6/B12/CHROM/ (C)           25/50/50/100/1MG/4MCG\t5 ML;  \t  METHIONINE/INOSITOL/CHOLINE/CHROMIUM W/O B-12 0.8/1.6/1.6/0.0001% INJECTABLE\t30 ML  (18 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-1572-2012",
      "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"
    }
  ]
}