{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090355"
        ],
        "brand_name": [
          "THEOPHYLLINE"
        ],
        "generic_name": [
          "THEOPHYLLINE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-356",
          "68462-380"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "THEOPHYLLINE ANHYDROUS"
        ],
        "rxcui": [
          "313291",
          "348472"
        ],
        "spl_id": [
          "7c8e32e3-ca36-4ad2-971b-446c12a81992"
        ],
        "spl_set_id": [
          "56fc2167-ceb6-4e3e-8ff7-5e400dfbd533"
        ],
        "package_ndc": [
          "68462-380-01",
          "68462-380-05",
          "68462-356-01",
          "68462-356-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462380017",
          "0368462356012"
        ],
        "nui": [
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_epc": [
          "Methylxanthine [EPC]"
        ],
        "pharm_class_cs": [
          "Xanthines [CS]"
        ],
        "unii": [
          "0I55128JYK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97406",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0583-2025",
      "product_description": "Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01",
      "product_quantity": "22,656 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.",
      "recall_initiation_date": "20250808",
      "center_classification_date": "20250812",
      "report_date": "20250820",
      "code_info": "Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026",
      "more_code_info": ""
    }
  ]
}