{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076737"
        ],
        "brand_name": [
          "TESTOSTERONE"
        ],
        "generic_name": [
          "TESTOSTERONE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2921",
          "0591-3216",
          "0591-3217"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TESTOSTERONE"
        ],
        "rxcui": [
          "1596780",
          "1597123",
          "1597129"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0591-2921-18",
          "0591-2921-02",
          "0591-3216-17",
          "0591-3216-30",
          "0591-3217-26",
          "0591-3217-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175824",
          "N0000000146",
          "M0001109"
        ],
        "pharm_class_epc": [
          "Androgen [EPC]"
        ],
        "pharm_class_moa": [
          "Androgen Receptor Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Androstanes [CS]"
        ],
        "unii": [
          "3XMK78S47O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90534",
      "recalling_firm": "Teva Pharmaceuticals USA Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1289-2022",
      "product_description": "Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30",
      "product_quantity": "12354 cartons",
      "reason_for_recall": "Superpotent Drug: Out of specification assay result was obtained during stability testing.",
      "recall_initiation_date": "20220629",
      "center_classification_date": "20220725",
      "termination_date": "20240315",
      "report_date": "20220803",
      "code_info": "Lot: 1403180, EXP. 10/2022",
      "more_code_info": ""
    }
  ]
}