{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204777"
        ],
        "brand_name": [
          "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION"
        ],
        "generic_name": [
          "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE"
        ],
        "manufacturer_name": [
          "Micro Labs Limited"
        ],
        "product_ndc": [
          "42571-147"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DORZOLAMIDE HYDROCHLORIDE",
          "TIMOLOL MALEATE"
        ],
        "rxcui": [
          "1923432"
        ],
        "spl_id": [
          "22ff7483-50ec-42c6-e063-6394a90ae1fa"
        ],
        "spl_set_id": [
          "f45cce05-fb47-4607-b68e-5a3d47e7235a"
        ],
        "package_ndc": [
          "42571-147-26"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0342571147266"
        ],
        "unii": [
          "QZO5366EW7",
          "P8Y54F701R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99481",
      "recalling_firm": "MICRO LABS USA INC",
      "address_1": "220 Davidson Ave",
      "address_2": "N/A",
      "postal_code": "08873-4149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0730-2026",
      "product_description": "Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.",
      "product_quantity": "N/A",
      "reason_for_recall": "Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.",
      "recall_initiation_date": "20260722",
      "center_classification_date": "20260724",
      "report_date": "20260805",
      "code_info": "Lot # DLHU0031, Exp Date: 06/30/2027."
    }
  ]
}