{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA217000"
        ],
        "brand_name": [
          "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Bionpharma Inc.,"
        ],
        "product_ndc": [
          "69452-206"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXYLAMINE SUCCINATE",
          "PYRIDOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1375948"
        ],
        "spl_id": [
          "4527bd89-c3ee-9cfe-e063-6294a90a3ebc"
        ],
        "spl_set_id": [
          "0c410285-0ad6-aabc-e063-6294a90abcd8"
        ],
        "package_ndc": [
          "69452-206-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V9BI9B5YI2",
          "68Y4CF58BV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99551",
      "recalling_firm": "Bionpharma Inc.",
      "address_1": "400 Alexander Park Ste 2-4b",
      "address_2": "N/A",
      "postal_code": "08540-6539",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0822-2026",
      "product_description": "Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.",
      "product_quantity": "14,232 bottles (1,423,200 tablets)",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules",
      "recall_initiation_date": "20260807",
      "center_classification_date": "20260828",
      "report_date": "20260909",
      "code_info": "Lot # DMA25006, Exp Date: 11/30/2028.",
      "more_code_info": ""
    }
  ]
}