{
  "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": "84672",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed throughout the United States.",
      "recall_number": "D-0788-2020",
      "product_description": "Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India",
      "product_quantity": "",
      "reason_for_recall": "cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.",
      "recall_initiation_date": "20200114",
      "center_classification_date": "20200116",
      "termination_date": "20200831",
      "report_date": "20200122",
      "code_info": "a)  JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, JKT0370A exp Jan-20;  JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, JKT0696A, exp Feb-20;  JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, JKT1066A exp Mar-20;  JKT1149A, JKT1147A, JKT1150A, JKT1427A, JKT1428A, JKT1426A, JKT1429A, JKT1540A, JKT1539A, JKT1541A, JKT1543A, JKT1542A exp Apr-20;  JKT1725A, JKT1574A, JKT1727A, JKT1863A, JKT1864A, JKT1865A, JKT1726A  exp May-20;  JKT2191A exp Jun-20;  JKT1866A, JKT2192A, JKT2193A, JKT2194A, JKT2575A, JKT2195A, JKT2576A  exp Jul-20;  JKT2578A, JKT2579A, JKT2911A, JKT2907A, JKT2908A, JKT2909A, JKT2910A, JKT2577A exp  Aug-20;  JKT3104A, JKT3105A, JKT3106A, JKT3260A, JKT3261A, JKT3263A, JKT3107A, JKT3467A, JKT3262A, JKT3264A exp Sep-20;  JKT3788A, JKT3468A, JKT3749A, JKT3469A, JKT3787A  exp Oct-20;  JKT3790A, JKT4019A, JKT3789A, JKT4016A, JKT4014A, JKT4017A, Nov-20;  JKU0040A exp Dec-20;  JKU0041A, JKU0042A, JKU1043A, JKU1044A exp Feb-21;    b)   JKT1862A, JKT1578A exp May-20;  JKT2000A, JKT1999A, JKT2001A exp Jun-20;  JKT2593A, JKT2594A exp Jul-20;  JKT3863A, JKT4013A exp Nov-20;  JKU0037A, JKU0038A, JKU0358A exp Dec-20",
      "more_code_info": ""
    }
  ]
}