{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209132"
        ],
        "brand_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "generic_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-161"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CISATRACURIUM BESYLATE"
        ],
        "rxcui": [
          "199211"
        ],
        "spl_id": [
          "16bbec4b-027e-470e-aac9-e041bc5e24f5"
        ],
        "spl_set_id": [
          "23daa1f8-2a07-449d-97a6-11efdb0b9836"
        ],
        "package_ndc": [
          "70069-161-01",
          "70069-161-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370069161012",
          "0370069161104"
        ],
        "unii": [
          "80YS8O1MBS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98063",
      "recalling_firm": "SOMERSET THERAPEUTICS LLC",
      "address_1": "300 Franklin Square Dr",
      "address_2": "",
      "postal_code": "08873-4187",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0238-2026",
      "product_description": "Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.",
      "product_quantity": "71,310 10mL vials",
      "reason_for_recall": "Subpotent product:out of specification assay results observed during long term stability testing.",
      "recall_initiation_date": "20251126",
      "center_classification_date": "20251215",
      "report_date": "20251224",
      "code_info": "Lot#: A250043, EXP Date 06/30/2026",
      "more_code_info": ""
    }
  ]
}