{
  "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": "79240",
      "recalling_firm": "LEADIANT BIOSCIENCES, INC",
      "address_1": "9841 Washingtonian Blvd Ste 500",
      "address_2": "N/A",
      "postal_code": "20878-7352",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to one specialty pharmacy distributor in the US  Walgreens Specialty Pharmacy  16287, 130 Enterprise Drive  Pittsburgh, PA 15275    Foreign Account: Italy",
      "recall_number": "D-0550-2018",
      "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": "1,705 bottles",
      "reason_for_recall": "Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.",
      "recall_initiation_date": "20180214",
      "center_classification_date": "20180228",
      "termination_date": "20181129",
      "report_date": "20180307",
      "code_info": "Lot #: 356075, Exp 2/28/18"
    }
  ]
}