{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA202099"
        ],
        "brand_name": [
          "ZENATANE"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-113",
          "55111-135",
          "55111-136",
          "55111-137"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
          "197843",
          "197844",
          "197845",
          "403930",
          "1373333",
          "1373335",
          "1373337",
          "1605088"
        ],
        "spl_id": [
          "d7d883f9-7d20-2c50-8023-e661b46dcd5b"
        ],
        "spl_set_id": [
          "27b3cf26-f22e-5b70-1c24-009933b7c6ee"
        ],
        "package_ndc": [
          "55111-135-79",
          "55111-135-81",
          "55111-136-79",
          "55111-136-81",
          "55111-137-79",
          "55111-137-81",
          "55111-113-79",
          "55111-113-81",
          "55111-113-78"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76539",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0509-2017",
      "product_description": "Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India, NDC 55111-135-81",
      "product_quantity": "4404 cartons",
      "reason_for_recall": "Failed dissolution specifications - low dissolution  results at S3 stage.",
      "recall_initiation_date": "20170215",
      "center_classification_date": "20170302",
      "termination_date": "20181219",
      "report_date": "20170308",
      "code_info": "Lot # KB60197, Exp 2/18",
      "more_code_info": ""
    }
  ]
}