{
  "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": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA213874"
        ],
        "brand_name": [
          "CYANOCOBALAMIN"
        ],
        "generic_name": [
          "CYANOCOBALAMIN"
        ],
        "manufacturer_name": [
          "AuroMedics Pharma LLC"
        ],
        "product_ndc": [
          "55150-364"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "CYANOCOBALAMIN"
        ],
        "rxcui": [
          "309594"
        ],
        "spl_id": [
          "a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "55150-364-01",
          "55150-364-10",
          "55150-364-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150364015",
          "0355150364107"
        ],
        "nui": [
          "M0022794",
          "N0000175951"
        ],
        "pharm_class_cs": [
          "Vitamin B 12 [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin B12 [EPC]"
        ],
        "unii": [
          "P6YC3EG204"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89941",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0766-2022",
      "product_description": "Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.",
      "product_quantity": "433,809 vials",
      "reason_for_recall": "Subpotent Drug: Out of Specification results for Assay",
      "recall_initiation_date": "20220405",
      "center_classification_date": "20220412",
      "termination_date": "20240627",
      "report_date": "20220420",
      "code_info": "Lots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023."
    }
  ]
}