{
  "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
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  },
  "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": "193 units",
      "code_info": "Rx #'s:  0389332    0388230      0362007    0362537    0369266    0369759    0376765      0376766    0378972    0381347    0381668    0383006    0384070    0387408    0387842    0387873    0388522    0388825    0389034    0389038    0389347    0389746    0389824    0389913    0390210    0390265    0390267    0390404    0390481    0391083    0391374    0391789    0392302    0392329    0393161    0393238    0393733    0393734    0394038    0396204    0396253    0396951    0397068    0397814    0397816    0398167    0398775    0398809    0399039      0399168      0400419      0401454    0401456    0401717    0402440    0402443    0403637    0377693    0382907    0389892    0390269    0393418    0397085    0397984    0398761    0401192    0401453    0401702    0402969    0403042    0353856    0380968        0389852    0396383    0396985      0397369    0405720    0409461    0400111    0392017    0405577    0405591    0407190    0390553            0410265    0393727    0394656    0399169    0403590      0392209    0392212    0392214    0392215    0392217    0394902    0395795    0395799    0395800    0395880      0395884      0395885      0398821    0399797    0403933    0405574    0405578    0405607    0405608    0406394    0410495    0394528    0395347    0392045    0393681    0393682    0394381    0396742    0396763    0401783    0401785    0405205    0404805    0397298      0398209    0401610    0404696    0406424    0408386    0408794    0409008    0409330    0409500    0409511    0410093    0410179    0410202    0410327    0394569    0397231    0400352    0400360    0410043    0410045    0410046    0394569    0394569    0407106    0407854    0409176    0408788    0394569      0405634    0394765    0405634    0392318    0394569    0373437    0381856    0387413    0397985    0398350    0394512    0401471    0404558    0393614    0397800    0387413    0406999    0397800    0397822    0388830      0380110    0407385    0380110",
      "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": "CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED  4,000 UNIT/40MCG/ML KIT 1 KIT, 2 KIT, 3 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED (HCG) 4,000 UNIT VIAL INJECTABLE 1 VIAL, 12 VIALS;  CHORIONIC GONADOTROPIN KIT 5,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN** KIT 10,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN, HUMAN - MINI 250 UNITS TROCHE 30 TROCHE, 45 TROCHE, 50 TROCHE, 60 TROCHE, 80 TROCHE; CHORIONIC GONADOTROPIN, LYOPHILIZED   (HCG) 1,000 UNIT VIAL INJECTABLE 30 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED   (HCG) 5,000 UNIT VIAL INJECTABLE 1 VIAL, 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 2 VIALS, 20 VIAL, 3 VIAL, 5 VIAL, 6 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED  (HCG) 125 UNIT VIAL (UNIT DOSE) INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL,\t2 VIAL, 24 VIAL, 28 VIAL, 28 VIALS, 7 VIAL,\t7 VIALS; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 2,500 UNIT VIAL INJECTABLE 5 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 200 UNIT VIAL (UNIT DOSE) INJECTABLE 22 VIAL, 25 VIAL, 8 VIAL (40 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-1483-2012",
      "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"
    }
  ]
}