{
  "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": "Piscataway",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA202843"
        ],
        "brand_name": [
          "MONTELUKAST SODIUM"
        ],
        "generic_name": [
          "MONTELUKAST SODIUM"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-726"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MONTELUKAST SODIUM"
        ],
        "rxcui": [
          "200224"
        ],
        "spl_id": [
          "30387eb8-222d-146e-e063-6294a90a12a7"
        ],
        "spl_set_id": [
          "97a682c2-7e00-4d07-a5ac-4436c977f842"
        ],
        "package_ndc": [
          "31722-726-30",
          "31722-726-90",
          "31722-726-01",
          "31722-726-10",
          "31722-726-31",
          "31722-726-32"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722726306"
        ],
        "unii": [
          "U1O3J18SFL"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76412",
      "recalling_firm": "Hetero USA Inc",
      "address_1": "1035 Centennial Ave",
      "address_2": "",
      "postal_code": "08854-4124",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0623-2017",
      "product_description": "Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob  Nagar - 509 301, India, NDC 31722-726-30",
      "product_quantity": "65,664 bottles",
      "reason_for_recall": "Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.",
      "recall_initiation_date": "20170107",
      "center_classification_date": "20170329",
      "termination_date": "20170808",
      "report_date": "20170405",
      "code_info": "Lot # MON16001B, Exp 01/18",
      "more_code_info": ""
    }
  ]
}