{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Livonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205618"
        ],
        "brand_name": [
          "PALIPERIDONE"
        ],
        "generic_name": [
          "PALIPERIDONE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6935",
          "0904-6936",
          "0904-6937"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PALIPERIDONE"
        ],
        "rxcui": [
          "672567",
          "672569",
          "672571"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "0904-6935-61",
          "0904-6936-61",
          "0904-6937-61"
        ],
        "original_packager_product_ndc": [
          "47335-765",
          "47335-766",
          "47335-767"
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "838F01T721"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89681",
      "recalling_firm": "The Harvard Drug Group",
      "address_1": "17187 N Laurel Park Dr Ste 300",
      "address_2": "N/A",
      "postal_code": "48152-2600",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0649-2022",
      "product_description": "PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61",
      "product_quantity": "174 cartons",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20220228",
      "center_classification_date": "20220309",
      "termination_date": "20230608",
      "report_date": "20220316",
      "code_info": "Lot #:  N00522, Exp. Date 09/2022;  N00618, Exp. Date 11/2022"
    }
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}