{
  "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": "Theda",
      "state": "N/A",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209361"
        ],
        "brand_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "generic_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-321"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOBETASOL PROPIONATE"
        ],
        "spl_id": [
          "7b4cca50-7139-4d48-8f4a-f8204fc46b2e"
        ],
        "spl_set_id": [
          "5ad9c808-6095-4d86-b140-e0f6d4079a3a"
        ],
        "package_ndc": [
          "33342-321-86",
          "33342-321-39",
          "3334203218"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342321398",
          "0333342321862"
        ],
        "unii": [
          "779619577M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81914",
      "recalling_firm": "Oxalis Labs",
      "address_1": "Lodhimajra",
      "address_2": "Tehsil - Baddi",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.",
      "recall_number": "D-0492-2019",
      "product_description": "Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc.  Plainsboro, NJ 08536  Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86",
      "product_quantity": "53,358 bottles",
      "reason_for_recall": "Defective Container; complaints of leakage.",
      "recall_initiation_date": "20190111",
      "center_classification_date": "20190214",
      "termination_date": "20191106",
      "report_date": "20190220",
      "code_info": "Lot Numbers:  PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020"
    }
  ]
}