{
  "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": "Ongoing",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA210432"
        ],
        "brand_name": [
          "PREGABALIN"
        ],
        "generic_name": [
          "PREGABALIN"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-410",
          "64980-411",
          "64980-412",
          "64980-413",
          "64980-414",
          "64980-415",
          "64980-416",
          "64980-417"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PREGABALIN"
        ],
        "rxcui": [
          "483438",
          "483440",
          "483442",
          "483444",
          "483446",
          "483448",
          "483450",
          "577127"
        ],
        "spl_id": [
          "ed8357e8-6f9d-4b09-b3f0-48417fe7f481"
        ],
        "spl_set_id": [
          "dbebfa61-0685-41b4-8364-00b8d8b73714"
        ],
        "package_ndc": [
          "64980-410-09",
          "64980-410-10",
          "64980-410-01",
          "64980-411-09",
          "64980-411-10",
          "64980-411-01",
          "64980-412-09",
          "64980-412-10",
          "64980-412-01",
          "64980-413-09",
          "64980-413-10",
          "64980-413-01",
          "64980-414-09",
          "64980-414-10",
          "64980-414-01",
          "64980-415-09",
          "64980-415-10",
          "64980-415-01",
          "64980-416-09",
          "64980-416-10",
          "64980-416-01",
          "64980-417-09",
          "64980-417-10",
          "64980-417-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980413107",
          "0364980411103",
          "0364980415101",
          "0364980412100",
          "0364980416108",
          "0364980414104",
          "0364980410106",
          "0364980417105"
        ],
        "unii": [
          "55JG375S6M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94642",
      "recalling_firm": "Rising Pharma Holding, Inc.",
      "address_1": "2 Tower Center Blvd Ste 1401",
      "address_2": "N/A",
      "postal_code": "08816-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0541-2024",
      "product_description": "Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10",
      "product_quantity": "N/A",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.",
      "recall_initiation_date": "20240516",
      "center_classification_date": "20240604",
      "report_date": "20240612",
      "code_info": "Lot: 23132611, Exp 07/31/2026",
      "more_code_info": ""
    }
  ]
}