{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209959"
        ],
        "brand_name": [
          "ALBUTEROL SULFATE"
        ],
        "generic_name": [
          "ALBUTEROL SULFATE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-142"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "ALBUTEROL SULFATE"
        ],
        "rxcui": [
          "2123111"
        ],
        "spl_id": [
          "135ef57d-f447-45c6-ad56-e4f772dc98ee"
        ],
        "spl_set_id": [
          "c4d6d76a-14b8-411a-8019-e2c923c2c532"
        ],
        "package_ndc": [
          "69097-142-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "021SEF3731"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97304",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0593-2025",
      "product_description": "Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.",
      "product_quantity": "20352 packs (1x 200 MD)",
      "reason_for_recall": "Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.",
      "recall_initiation_date": "20250724",
      "center_classification_date": "20250820",
      "report_date": "20250827",
      "code_info": "Lot#: 4IB0519, Exp. 04/30/2026"
    }
  ]
}