{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA080737"
        ],
        "brand_name": [
          "CYANOCOBALAMIN"
        ],
        "generic_name": [
          "CYANOCOBALAMIN"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-0031",
          "0517-0032",
          "0517-0130"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "CYANOCOBALAMIN"
        ],
        "rxcui": [
          "309594"
        ],
        "spl_id": [
          "28421ba1-7e37-429c-9c66-62cc36f5847c"
        ],
        "spl_set_id": [
          "2fb653d6-e2b2-4969-831b-c0dc37b9c0cc"
        ],
        "package_ndc": [
          "0517-0031-01",
          "0517-0031-25",
          "0517-0032-01",
          "0517-0032-25",
          "0517-0130-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305170031251",
          "0305170032258"
        ],
        "nui": [
          "M0022794",
          "N0000175951"
        ],
        "pharm_class_cs": [
          "Vitamin B 12 [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin B12 [EPC]"
        ],
        "unii": [
          "P6YC3EG204"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0793-2026",
      "product_description": "Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.",
      "product_quantity": "26,450 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 25082, Exp. Date: 3/31/2027.",
      "more_code_info": ""
    }
  ]
}