{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078895"
        ],
        "brand_name": [
          "CLONIDINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "CLONIDINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "29300-136",
          "29300-468",
          "29300-137",
          "29300-135"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLONIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "884173",
          "884185",
          "884189"
        ],
        "spl_id": [
          "d015993c-74da-4faa-9e51-727d6d93a867"
        ],
        "spl_set_id": [
          "21bfa28f-20df-43fd-bb80-b720d3b40696"
        ],
        "package_ndc": [
          "29300-468-05",
          "29300-468-10",
          "29300-468-50",
          "29300-468-01",
          "29300-136-01",
          "29300-136-05",
          "29300-136-10",
          "29300-136-50",
          "29300-137-01",
          "29300-137-05",
          "29300-137-10",
          "29300-137-25",
          "29300-135-01",
          "29300-135-05",
          "29300-135-10",
          "29300-135-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0329300137019",
          "0329300136012",
          "0329300135015",
          "0329300468014"
        ],
        "unii": [
          "W76I6XXF06"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90709",
      "recalling_firm": "UNICHEM PHARMACEUTICALS USA INC",
      "address_1": "1 Tower Center Blvd Ste 2200",
      "address_2": "N/A",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-1541-2022",
      "product_description": "Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01",
      "product_quantity": "18,960 bottles of 100",
      "reason_for_recall": "Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,",
      "recall_initiation_date": "20220919",
      "center_classification_date": "20220922",
      "termination_date": "20230302",
      "report_date": "20220928",
      "code_info": "Lot # GCLH22005, exp. date 02/29/2024"
    }
  ]
}