{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedminster",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203269"
        ],
        "brand_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "generic_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-261",
          "67877-262"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RIZATRIPTAN BENZOATE"
        ],
        "rxcui": [
          "312840",
          "314209"
        ],
        "spl_id": [
          "9fd3ccaa-ae93-475b-9591-5c4af70f51c5"
        ],
        "spl_set_id": [
          "07e66554-bc85-4853-9f40-1249617630a9"
        ],
        "package_ndc": [
          "67877-261-30",
          "67877-261-01",
          "67877-261-05",
          "67877-261-18",
          "67877-261-25",
          "67877-262-30",
          "67877-262-01",
          "67877-262-05",
          "67877-262-18",
          "67877-262-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367877261300"
        ],
        "unii": [
          "WR978S7QHH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96770",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "135 Us Highway 202 206 Ste 15",
      "address_2": "N/A",
      "postal_code": "07921-2608",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0534-2025",
      "product_description": "Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.",
      "recall_initiation_date": "20250709",
      "center_classification_date": "20250717",
      "report_date": "20250723",
      "code_info": "Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142623, Exp Date: May 2027;  Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027."
    }
  ]
}