{
  "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": "224 units",
      "code_info": "Rx #'s:   0389516    0354047    0389060    0389207      0405939    0402042    0400827    0398001    0398001    0400827    0403914    0369558    0398001    0398001    0382651                                0398001    0401260    0401260    0388232    0391059      0392294    0405026    0383386      0396250      0398226    0400971    0409026    0388709    0388791    0393212      0393212    0388791    0392126    0354819    0355230    0363386    0363473    0364197    0368230      0368499      0368573    0368881    0375045    0379341    0379553        0383464    0387849      0389351      0389391    0390955      0392188    0394445    0394681    0394937    0395427    0395954      0396732    0397082    0404021      0404798    0405706    0406017    0408990    0409845    0365234    0393460    0359175    0348859    0351904    0356879    0363386    0364197    0364237    0365742    0366033      0366278    0374625      0375045      0376068      0376172    0380555      0383380    0384293    0387373    0387484    0388897    0392019    0392074      0392237    0394445    0395775    0395954    0397082      0399965    0399990    0403522    0404021    0405332    0407337    0384730    0387512    0389305      0396300      0353129    0355934    0362691        0363386    0363664    0364588    0368573      0368881      0371798      0375690    0376829      0380347    0383380    0387484    0388897    0392019    0392331    0392542    0392778    0394517    0395954    0395388    0355439    0358613    0362691    0366278    0375410    0375512    0375513    0375516    0375517    0375520    0375690    0384293      0387482    0392331    0408623    0376092    0399725    0354424    0392778    0405107    0408480    0408826    0373371      0375355        0375502      0375505      0375508    0375509      0375512    0375513    0375516    0375517    0375520    0392019    0392331    0395775    0398876    0368828    0392019    0358047    0387426    0391713    0393523    0404318    0391713    0391703    0402014      0391703",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE\t400 ML;  VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE\t0.1 ML  \t  \t  \t  \t  \t0.2 ML  \t1 ML  \t100 ML  \t150 ML  \t2 ML  \t  \t2 MLS  \t5 ML  \t50 ML  \t6 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t95 ML;  VANCOMYCIN HCL, FTV** 1GM INJECTABLE\t3 VIAL  \t4 VIAL;  VANCOMYCIN, FORTIFIED 1% (10MG/ML) OPHTHALMIC\t10 ML;  \t  \t  \t  VANCOMYCIN, FORTIFIED 1.5% (15MG/ML) OPHTHALMIC\t15 ML;  VANCOMYCIN, FORTIFIED 2% (20MG/ML) OPHTHALMIC\t10 ML  \t  \t  \t  \t15 ML;  VANCOMYCIN, FORTIFIED 2.5% (25MG/ML) OPHTHALMIC\t10 ML  \t  \t15 ML;  VANCOMYCIN, FORTIFIED 5% (50MG/ML) OPHTHALMIC\t10 ML  \t  \t  \t15 ML  \t5 ML;  \t  VANCOMYCIN, LYOPHILIZED, OPHTHALMIC KIT 1% KIT\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  \t1 VIAL  \t  \t14 KIT  \t2 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  \t2 KITS  \t20 KIT  \t  \t  \t  \t  \t3 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  \t3 KITS  \t4 KIT  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t4 KITS  \t4 VIALS  \t5 KIT  \t  \t  \t  \t  \t6 KIT  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t6 VIAL  \t9 KIT;  VANCOMYCIN, SDPF - (0.2ML SYRINGE, 30G, 1/2\") 1% INJECTABLE\t0.4 ML  \t  \t0.6 ML  \t0.8 ML  \t  \t1 ML  \t1.2 ML  \t  \t  \t1.6 ML  (44 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-1638-2012",
      "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"
    }
  ]
}