{
  "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": "Completed",
      "city": "Jadcherla Mandal, Mahaboob Nagar",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203311"
        ],
        "brand_name": [
          "VALSARTAN"
        ],
        "generic_name": [
          "VALSARTAN"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-745",
          "31722-746",
          "31722-747",
          "31722-748"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALSARTAN"
        ],
        "rxcui": [
          "349199",
          "349200",
          "349201",
          "349483"
        ],
        "spl_id": [
          "2b44fd7a-fd5a-984d-e063-6294a90a3fff"
        ],
        "spl_set_id": [
          "0ff36e83-b307-42db-a2ab-bae3f6805c20"
        ],
        "package_ndc": [
          "31722-745-30",
          "31722-745-90",
          "31722-745-05",
          "31722-745-31",
          "31722-745-32",
          "31722-746-30",
          "31722-746-90",
          "31722-746-05",
          "31722-746-31",
          "31722-746-32",
          "31722-747-30",
          "31722-747-90",
          "31722-747-05",
          "31722-747-31",
          "31722-747-32",
          "31722-748-30",
          "31722-748-90",
          "31722-748-05",
          "31722-748-31",
          "31722-748-32",
          "3317227479"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "80M03YXJ7I"
        ],
        "upc": [
          "331722747905"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80773",
      "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",
      "recall_number": "D-1115-2018",
      "product_description": "Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only   Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854   By: Hetero Hetero Labs Limited, Unit V, Pollepally  Jadcherla Mahabubnagar - 509-301, India.   NDC 31722-747-90  UPC 331722747905",
      "product_quantity": "441,408 bottles",
      "reason_for_recall": "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.",
      "recall_initiation_date": "20180808",
      "center_classification_date": "20180823",
      "report_date": "20180829",
      "code_info": "All Lots with expiration dates 7/2018 to 6/2020",
      "more_code_info": ""
    }
  ]
}