{
  "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": "188 units",
      "code_info": "Rx #'s:  0406657    0405526    0391965    0393529    0390040    0362442      0370756    0378145    0386548    0393611    0394410    0394751    0394753    0395981      0397434    0398818    0399650    0399825    0399848    0399854    0400112    0401949    0404137    0404138    0404295    0405528    0405700    0407504    0407507    0407770    0408225    0408229    0408670    0410088    0370756      0376063    0391443    0397137        0397222      0397227    0402055    0406817    0391443    0362442      0375777          0390216        0392072    0392079    0392091      0395270    0395277    0395284    0398284    0400112    0403421    0370756                  0391443      0362395    0374541    0375777        0395538    0407969    0391443    0374541      0376063    0395987    0395989    0397137    0402055    0387769    0370756    0374541    0376063    0374541    0383057    0385833    0387137    0387361      0387564    0387810    0388478    0390588        0391303    0392314    0392586      0393046    0393339    0394113    0394120    0395617      0395663    0395677    0396139    0397002    0397162    0397275    0397424    0397438    0397462    0397528    0397934    0398287    0398574    0398695    0398774    0399172    0399416    0399658    0399659    0399766      0399862    0400268    0400583    0400688      0400834    0401416    0401429    0401445    0401476    0401499    0401683    0401771    0402350    0403007    0403151      0403488    0403593    0403594    0403874      0404051    0404293    0404566    0404649    0404671    0404837    0404856    0404868    0404916    0405436    0405907    0405938    0406152    0406239    0406886    0407034    0407563    0408732    0381970    0388666    0402009    0376106        0393514    0405150",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE\t10 ML  \t150 ML  \t30 ML;  \t  MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC\t6 ML;  MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE\t1 VIAL  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t10 VIAL  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t15 VIAL  \t2 VIAL  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t20 VIAL  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t4 VIAL  \t  \t  \t  \t  \t  \t  \t40 VIAL  \t5 VIAL  \t  \t  \t  \t  \t  \t  \t50 VIAL  \t6 VIAL  \t  \t7 VIAL  \t8 VIAL  MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE\t1 KIT  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t2 KIT  \t  \t  \t4 KIT  \t  \t  MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA\t1 KIT  (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-1579-2012",
      "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"
    }
  ]
}