{
  "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": "Hyderabad",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205064"
        ],
        "brand_name": [
          "ARIPIPRAZOLE"
        ],
        "generic_name": [
          "ARIPIPRAZOLE"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-819",
          "31722-820",
          "31722-827",
          "31722-828",
          "31722-829",
          "31722-830"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARIPIPRAZOLE"
        ],
        "rxcui": [
          "349490",
          "349545",
          "349547",
          "349553",
          "402131",
          "602964"
        ],
        "spl_id": [
          "10628de5-d649-12ef-e063-6394a90ae380"
        ],
        "spl_set_id": [
          "2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa"
        ],
        "package_ndc": [
          "31722-820-30",
          "31722-820-01",
          "31722-820-31",
          "31722-820-32",
          "31722-820-05",
          "31722-827-30",
          "31722-827-01",
          "31722-827-31",
          "31722-827-32",
          "31722-827-05",
          "31722-819-30",
          "31722-819-01",
          "31722-819-31",
          "31722-819-32",
          "31722-819-05",
          "31722-828-30",
          "31722-828-01",
          "31722-828-31",
          "31722-828-32",
          "31722-828-05",
          "31722-829-30",
          "31722-829-01",
          "31722-829-31",
          "31722-829-32",
          "31722-829-05",
          "31722-830-30",
          "31722-830-01",
          "31722-830-31",
          "31722-830-32",
          "31722-830-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722828055",
          "0331722820301"
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "82VFR53I78"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78809",
      "recalling_firm": "Hetero Labs, Ltd. - Unit III",
      "address_1": "Plot 22-110, Part Ii, Ida",
      "address_2": "Rangareddy, Jeedimetla",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ Only",
      "recall_number": "D-0594-2018",
      "product_description": "Aripiprazole Tablets, USP, 10 mg, 30-count bottles,  Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30",
      "product_quantity": "3000  bottles",
      "reason_for_recall": "CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.",
      "recall_initiation_date": "20180110",
      "center_classification_date": "20180313",
      "termination_date": "20200921",
      "report_date": "20180214",
      "code_info": "Lot #: ARI17089, ARI17090, Exp. 5/2019"
    }
  ]
}