{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205811"
        ],
        "brand_name": [
          "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2132"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXYLAMINE SUCCINATE",
          "PYRIDOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1375948"
        ],
        "spl_id": [
          "a51f5dfd-c4ff-4fea-8a7c-1fc058cd7c11"
        ],
        "spl_set_id": [
          "3670d66e-c1e4-42ce-8760-c3d5accad925"
        ],
        "package_ndc": [
          "0591-2132-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V9BI9B5YI2",
          "68Y4CF58BV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89422",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "400 Interpace Pkwy",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0461-2022",
      "product_description": "Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01",
      "product_quantity": "6205 100-count bottles",
      "reason_for_recall": "Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient",
      "recall_initiation_date": "20220118",
      "center_classification_date": "20220128",
      "termination_date": "20221221",
      "report_date": "20220209",
      "code_info": "Lot#  100025842, 100028023,  Exp Date 08/2023"
    }
  ]
}