{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078939"
        ],
        "brand_name": [
          "ETHAMBUTOL HYDROCHLORIDE"
        ],
        "generic_name": [
          "ETHAMBUTOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-280",
          "68180-281"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ETHAMBUTOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "995599",
          "995607"
        ],
        "spl_id": [
          "b76b5b09-9d5d-4343-b128-0266024919b8"
        ],
        "spl_set_id": [
          "c732b415-e1f9-478f-896d-1dc8b6362da4"
        ],
        "package_ndc": [
          "68180-280-01",
          "68180-281-01",
          "68180-281-02",
          "68180-281-11"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180281016",
          "0368180280019",
          "368180281016"
        ],
        "unii": [
          "QE4VW5FO07"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66065",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21st",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-346-2014",
      "product_description": "Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.",
      "product_quantity": "4896 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.",
      "recall_initiation_date": "20130222",
      "center_classification_date": "20131212",
      "termination_date": "20131230",
      "report_date": "20131218",
      "code_info": "Lot #: 3122856, Exp 05/14",
      "more_code_info": ""
    }
  ]
}