{
  "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": "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": "96867",
      "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": "Nationwide in the USA",
      "recall_number": "D-0452-2025",
      "product_description": "Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.  NDC: 68462-356-01",
      "product_quantity": "8,520 100-count bottles",
      "reason_for_recall": "OOS results reported for the Dissolution (by UV) test.",
      "recall_initiation_date": "20250515",
      "center_classification_date": "20250528",
      "report_date": "20250604",
      "code_info": "Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26"
    }
  ]
}