{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA020898"
        ],
        "brand_name": [
          "THYROGEN"
        ],
        "generic_name": [
          "THYROTROPIN ALFA"
        ],
        "manufacturer_name": [
          "Genzyme Corporation"
        ],
        "product_ndc": [
          "58468-0030",
          "58468-1849"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "THYROTROPIN ALFA"
        ],
        "rxcui": [
          "2166572",
          "2166573",
          "2166578",
          "2166579",
          "2554801",
          "2554802",
          "2554804",
          "2554805"
        ],
        "spl_id": [
          "a62de867-ea60-47eb-873a-788223a1181f"
        ],
        "spl_set_id": [
          "b52dfa36-f90b-4e19-9b5e-26db9d04df2b"
        ],
        "package_ndc": [
          "58468-0030-1",
          "58468-0030-2",
          "58468-1849-4"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175949",
          "M0021496"
        ],
        "pharm_class_epc": [
          "Thyroid Stimulating Hormone [EPC]"
        ],
        "pharm_class_cs": [
          "Thyrotropin [CS]"
        ],
        "unii": [
          "AVX3D5A4LM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73301",
      "recalling_firm": "Genzyme Corporation",
      "address_1": "500 Kendall Street",
      "address_2": "675 West Kendall/55 Cambridge Parkway",
      "postal_code": "02142-1108",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.",
      "recall_number": "D-0730-2016",
      "product_description": "Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.",
      "product_quantity": "4669 Cartons",
      "reason_for_recall": "Presence of Particulate Matter: Glass particles found in the product after reconstitution.",
      "recall_initiation_date": "20160216",
      "center_classification_date": "20160226",
      "termination_date": "20170302",
      "report_date": "20160309",
      "code_info": "Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017"
    }
  ]
}