{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Wilmington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206368"
        ],
        "brand_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "generic_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "52536-625"
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        "product_type": [
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        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "rxcui": [
          "835840",
          "2047882"
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        "spl_id": [
          "3ab32628-1fbc-e980-e063-6394a90a81c4"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "52536-625-01",
          "52536-625-10"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "M0XW1UBI14"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91710",
      "recalling_firm": "Azurity Pharmaceuticals, Inc.",
      "address_1": "841 Woburn St",
      "address_2": "",
      "postal_code": "01887-3414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0489-2023",
      "product_description": "Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.",
      "product_quantity": "a) 16,471 vials; b) 43,096 vials",
      "reason_for_recall": "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.",
      "recall_initiation_date": "20230215",
      "center_classification_date": "20230331",
      "termination_date": "20231204",
      "report_date": "20230412",
      "code_info": "Lot #23804.034A, 23803.061A, Exp 9/2024",
      "more_code_info": ""
    }
  ]
}