{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071525"
        ],
        "brand_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "50111-450",
          "50111-560",
          "50111-561"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRAZODONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "856364",
          "856373",
          "856377"
        ],
        "spl_id": [
          "3313a8d0-eb39-47a4-b476-0973aad30e02"
        ],
        "spl_set_id": [
          "4006d439-e2de-4590-82e9-fc9d56e3ec1b"
        ],
        "package_ndc": [
          "50111-560-01",
          "50111-560-02",
          "50111-560-03",
          "50111-561-01",
          "50111-561-02",
          "50111-561-03",
          "50111-450-01",
          "50111-450-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0350111450011"
        ],
        "unii": [
          "6E8ZO8LRNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99734",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0834-2026",
      "product_description": "traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01",
      "product_quantity": "175,392 bottles",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules",
      "recall_initiation_date": "20260824",
      "center_classification_date": "20260908",
      "report_date": "20260909",
      "code_info": "Lot: 1394026, Exp. 02/2028.",
      "more_code_info": ""
    }
  ]
}