{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lakewood",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "80442",
      "recalling_firm": "Renaissance Lakewood, LLC",
      "address_1": "1200 Paco Way",
      "address_2": "N/A",
      "postal_code": "08701-5938",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1033-2018",
      "product_description": "Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.",
      "product_quantity": "12088 bags",
      "reason_for_recall": "Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.",
      "recall_initiation_date": "20180711",
      "center_classification_date": "20180802",
      "termination_date": "20220309",
      "report_date": "20180808",
      "code_info": "Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19"
    }
  ]
}