{
  "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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
      "address_2": "",
      "product_quantity": "73 units",
      "code_info": "Rx #'s:  0406046    0397385    0366980      0395509    0387345    0387381    0387586    0387752    0391041    0391584    0394112    0394246    0395288    0397054    0397946    0399555    0400910    0401208    0403442    0404123    0408115    0388847    0388144    0388144    0395892    0389202    0373332          0378850    0388550    0392222    0373332      0378850    0388550        0373332    0373332    0378850    0358046    0376175    0392337      0375442    0392337    0377047    0381838        0388945    0407636    0371528        0375458      0375458    0400150    0368414    0366367    0389059    0392819    0407227    0368231    0390906    0405998    0364593    0409797    0364593",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies",
      "state": "FL",
      "product_description": "DEXAMETHASONE  SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML;  DEXAMETHASONE / LIDOCAINE  0.5%/3% INJECTABLE 30 MLS;  DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS)  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t40 ML  DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16\" ) 0.4MG/ML INJECTABLE\t0.3 ML  \t0.5 ML  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE\t0.05 ML  \t1 ML  \t16 ML  \t  \t  \t  \t  \t2 ML  \t  \t24 ML  \t  \t  \t3 ML  \t  \t  \t32 ML  \t8 ML  \t  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE\t0.4 ML  \t2 ML  \t3 ML  \t  \t5 ML  \t6 ML  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE\t100 ML  \t40 ML  \t  \t  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE\t0.1 ML  DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE\t50 ML  DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE\t100 ML  \t  \t  \t180 MLS  \t  \t240 MLS  \t30 ML  \t60 ML  DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE\t1 ML  \t  \t  DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE\t30 ML  DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC\t15 ML  \t  \t  DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2\") 80MG/ML INJECTABLE\t0.35 ML  \t  \t0.7 ML",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab",
      "recall_number": "D-1497-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "62416",
      "termination_date": "20140813",
      "more_code_info": "",
      "recall_initiation_date": "20120525",
      "postal_code": "34474-5138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}