{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Jadcherla Mandal, Mahaboob Nagar",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "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": "81029",
      "recalling_firm": "Hetero Labs Limited Unit V",
      "address_1": "Unit V (SEZ Unit I in APIIC SEZ)",
      "address_2": "Surv. No. 439-441, 458, Polepally Vill.",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1213-2018",
      "product_description": "Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only,  By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.",
      "product_quantity": "98,016 bottles",
      "reason_for_recall": "Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.",
      "recall_initiation_date": "20180820",
      "center_classification_date": "20180926",
      "termination_date": "20211105",
      "report_date": "20181003",
      "code_info": "Lot #: MON17355, Exp 12/19",
      "more_code_info": ""
    }
  ]
}