{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203147"
        ],
        "brand_name": [
          "RIZATRIPTAN"
        ],
        "generic_name": [
          "RIZATRIPTAN"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-087",
          "33342-088"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "rxcui": [
          "312840",
          "314209"
        ],
        "spl_id": [
          "fe80232a-c329-47ed-8edd-7786e06f3c08"
        ],
        "spl_set_id": [
          "27bc2cfc-fefb-4b50-a0dc-6268c69b4902"
        ],
        "package_ndc": [
          "33342-087-07",
          "33342-087-46",
          "33342-087-12",
          "33342-087-52",
          "33342-087-50",
          "33342-087-72",
          "33342-087-02",
          "33342-087-45",
          "33342-087-41",
          "33342-088-07",
          "33342-088-46",
          "33342-088-12",
          "33342-088-52",
          "33342-088-50",
          "33342-088-72",
          "33342-088-02",
          "33342-088-45",
          "33342-088-41"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342088468",
          "0333342087072",
          "0333342088079",
          "0333342087461"
        ],
        "unii": [
          "WR978S7QHH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88872",
      "recalling_firm": "MACLEODS PHARMA USA, INC",
      "address_1": "103 College Rd E Fl 2",
      "address_2": "N/A",
      "postal_code": "08540-6611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0078-2022",
      "product_description": "Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA",
      "product_quantity": "135,082 Blister Packs/2,431,476 tablets",
      "reason_for_recall": "Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.",
      "recall_initiation_date": "20211018",
      "center_classification_date": "20211028",
      "termination_date": "20240424",
      "report_date": "20211103",
      "code_info": "Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024"
    }
  ]
}