{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lenoir",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA210660"
        ],
        "brand_name": [
          "ELCYS"
        ],
        "generic_name": [
          "CYSTEINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Exela Pharma Sciences, LLC"
        ],
        "product_ndc": [
          "51754-1007"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CYSTEINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1667993",
          "2169281"
        ],
        "spl_id": [
          "04b033f6-7334-4aed-930f-beb3c349f193"
        ],
        "spl_set_id": [
          "e7652275-1c53-490c-82ad-e63867df5788"
        ],
        "package_ndc": [
          "51754-1007-1",
          "51754-1007-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "ZT934N0X4W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93265",
      "recalling_firm": "Exela Pharma Sciences LLC",
      "address_1": "1245 Blowing Rock Blvd",
      "address_2": "N/A",
      "postal_code": "28645-3618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0118-2024",
      "product_description": "ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).",
      "product_quantity": "38,200 vials",
      "reason_for_recall": "Presence of Particulate Matter: Silicone",
      "recall_initiation_date": "20231018",
      "center_classification_date": "20231122",
      "report_date": "20231129",
      "code_info": "Lot # 10000798, Expiration Date 03/31/2025",
      "more_code_info": ""
    }
  ]
}