{
  "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": "Ongoing",
      "city": "Jadcherla Mandal, Mahaboob Nagar",
      "state": "",
      "country": "India",
      "classification": "Class I",
      "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": "80803",
      "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": "U.S.A. Nationwide",
      "recall_number": "D-0081-2019",
      "product_description": "Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30",
      "product_quantity": "98016 bottles",
      "reason_for_recall": "Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.",
      "recall_initiation_date": "20180815",
      "center_classification_date": "20181017",
      "report_date": "20181003",
      "code_info": "Lot #: MON17384, Exp 12/19",
      "more_code_info": ""
    }
  ]
}