{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201720"
        ],
        "brand_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "generic_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-015",
          "62756-017",
          "62756-016"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "rxcui": [
          "835829",
          "835840",
          "2047882"
        ],
        "spl_id": [
          "bf24bb84-d12f-44e7-98bd-46f3aa792bcc"
        ],
        "spl_set_id": [
          "3653a602-4551-4e6c-84a7-31861f5dc482"
        ],
        "package_ndc": [
          "62756-017-40",
          "62756-015-40",
          "62756-016-40"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756017405",
          "0362756015401",
          "0362756016408"
        ],
        "unii": [
          "M0XW1UBI14"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80485",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "N/A",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0977-2018",
      "product_description": "Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40",
      "product_quantity": "5215 units",
      "reason_for_recall": "Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.",
      "recall_initiation_date": "20180712",
      "center_classification_date": "20180724",
      "termination_date": "20190311",
      "report_date": "20180801",
      "code_info": "Lot #: JKS0280A, Exp. 06/2019"
    }
  ]
}