{
  "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": "92 units",
      "code_info": "Rx #'s:N0396046  N0397450  N0404861  N0404320  N0389241  N0398238  N0408869  N0396836  N0390297  N0393345  N0393647  N0395395  N0397377  N0400800  N0403100  N0405536  N0408890  N0390024  N0391848  N0398239  N0403727  N0386864  N0388540  N0391192  N0391588  N0391831  N0391832  N0395396  N0396449  N0403824  N0403830  N0405260  N0405432  N0406253  N0407952  N0408884  N0393648  N0408194  N0394358  N0397366  N0397367  N0398708  N0398710  N0399636  N0400170  N0403098  N0405257  N0391608  N0401173  N0403253  N0405115  N0406436  N0390298  N0395170  N0407252  N0407520  N0392176  N0399300  N0406567  N0407428  N0387601  N0401757  N0388225  N0388588  N0392887  N0395240  N0398236  N0400870  N0404729  N0408213  N0399681  N0394427  N0388559  N0402004  N0386844  N0406159  N0390186  N0396640  N0404315  N0388587  N0402386  N0409165  N0389663  N0392048  N0387598  N0395522  N0396441  N0403779  N0405538  N0406915  N0399871  N0407182",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "MORPHINE SULFATE 2MG/ML INJECTABLE\t10 ML;  MORPHINE SULFATE MDV 10MG/ML INJECTABLE\t10 ML  \t25 ML  \t30 ML;  MORPHINE SULFATE, P.F. (0.9%  SODIUM CHLORIDE) 50MG/ML INTRATHECAL\t18 ML  \t  \t  \t40 ML;  MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL\t40 ML;  \t  \t  \t  \t  \t  \t  \t  \t  MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL\t18 ML  \t  \t  \t  \t40 ML;  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL\t20 ML  \t  \t40 ML;  \t  \t  \t  \t  \t  \t  \t  MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL\t50 ML;  MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL\t40 ML;  \t  \t  \t  \t  MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL\t40 ML;  \t  \t  \t  MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL\t35 ML;  \t  \t  MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE\t250 ML;  MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL\t30 ML;  \t  MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL\t18 ML;  \t  \t  \t  \t  \t  \t  \t  MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL\t30 ML;  MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL\t35 ML;  MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL\t18 ML  \t  \t20 ML  \t  \t35 ML;  \t  \t  MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL\t35 ML;  \t  \t  MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL\t18 ML  \t  \t40 ML;  \t  \t  \t  \t  MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL\t40 ML;  MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL\t18 ML  (28 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-1585-2012",
      "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"
    }
  ]
}