{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211881"
        ],
        "brand_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "generic_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-579"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "rxcui": [
          "808917"
        ],
        "spl_id": [
          "80c866f4-c984-469e-b2a5-5c23f29b9750"
        ],
        "spl_set_id": [
          "d101b5d8-bffc-4ee6-b93b-4589fcb8750d"
        ],
        "package_ndc": [
          "69097-579-67"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7FXW6U30GY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99930",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0014-2027",
      "product_description": "Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20260918",
      "center_classification_date": "20261006",
      "report_date": "20261014",
      "code_info": "Lot#: 5KA0405, Exp 12/31/2026."
    }
  ]
}