{
  "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": "Gaithersburg",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA200740"
        ],
        "brand_name": [
          "CYSTARAN"
        ],
        "generic_name": [
          "CYSTEAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Leadiant Biosciences, Inc."
        ],
        "product_ndc": [
          "54482-020",
          "54482-035"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "CYSTEAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1313780",
          "1313785"
        ],
        "spl_id": [
          "0ae95603-411c-455b-8bb8-8c5b01dac297"
        ],
        "spl_set_id": [
          "b98ee838-ed23-42a9-93b5-72579e490fba"
        ],
        "package_ndc": [
          "54482-020-01",
          "54482-020-02",
          "54482-035-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "IF1B771SVB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79849",
      "recalling_firm": "LEADIANT BIOSCIENCES, INC",
      "address_1": "9841 Washingtonian Blvd Ste 500",
      "address_2": "",
      "postal_code": "20878-7352",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Walgreens Specialty Pharmacy Pittsburg, PA  Italy and Germany",
      "recall_number": "D-0683-2018",
      "product_description": "Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01",
      "product_quantity": "3,398 bottles",
      "reason_for_recall": "Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.",
      "recall_initiation_date": "20180409",
      "center_classification_date": "20180417",
      "termination_date": "20181129",
      "report_date": "20180425",
      "code_info": "lot numbers: 35866, Exp 6/18; 358663, Exp 7/18",
      "more_code_info": ""
    }
  ]
}