{
  "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": "22 units",
      "code_info": "Rx #'s:   0391307      0387323    0394852    0390852    0391092    0391452    0391582    0387323    0387323    0402850      0409602    0388849    0395801    0401312    0362629      0393748      0405277    0391772",
      "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 25MG/75MG/75MG/ML INJECTABLE\t30 ML;  \t  METHIONINE/INOSITOL/CHOLINE CHLORIDE  0.8%/1.6%/1.6% INJECTABLE\t180 ML  \t  \t24 ML  \t  \t  \t  \t240 ML  \t270 ML  \t30 ML  \t  \t  \t90 ML  \t  METHIONINE/INOSITOL/CHOLINE CHLORIDE  25MG/50MG/50MG/ML INJECTABLE\t120 ML  \t300 ML  \t  \t  \t  \t  METHIONINE/INOSITOL/CHOLINE CHLORIDE/B1/B2 0.8%/1.6%/1.6% INJECTABLE\t60 ML  (10 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-1571-2012",
      "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"
    }
  ]
}