{
  "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-1123-2019",
      "product_description": "Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-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 69097-537-37.",
      "product_quantity": "12234 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 #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020."
    }
  ]
}