{
  "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": "Central Islip",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA210362"
        ],
        "brand_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "generic_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-536",
          "69097-537"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "TESTOSTERONE CYPIONATE"
        ],
        "rxcui": [
          "835829",
          "835840",
          "2047882"
        ],
        "spl_id": [
          "0fb2cc28-39a1-4a94-a01d-23209732dfd7"
        ],
        "spl_set_id": [
          "78d55bad-4a5b-4e21-aeb8-a4c6346208be"
        ],
        "package_ndc": [
          "69097-536-37",
          "69097-537-37",
          "69097-537-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369097536374",
          "0369097537371",
          "0369097537319"
        ],
        "unii": [
          "M0XW1UBI14"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82463",
      "recalling_firm": "InvaGen Pharmaceuticals, Inc.",
      "address_1": "550 S Research Pl",
      "address_2": "N/A",
      "postal_code": "11722-4415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.A.",
      "recall_number": "D-1124-2019",
      "product_description": "Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.",
      "product_quantity": "692538 vials",
      "reason_for_recall": "Presence of Particulate Matter.",
      "recall_initiation_date": "20190322",
      "center_classification_date": "20190415",
      "termination_date": "20220816",
      "report_date": "20190424",
      "code_info": "Lot #:GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020"
    }
  ]
}