{
  "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": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA214554"
        ],
        "brand_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "generic_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-749"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FOSFOMYCIN TROMETHAMINE"
        ],
        "rxcui": [
          "808917"
        ],
        "spl_id": [
          "0ebb79a9-df22-4fec-b872-b020b5129b14"
        ],
        "spl_set_id": [
          "48e352bc-52ea-4778-905a-60ef38a5c18a"
        ],
        "package_ndc": [
          "67877-749-57"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367877749570"
        ],
        "unii": [
          "7FXW6U30GY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92706",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "339 Jefferson Rd Ste 101",
      "address_2": "N/A",
      "postal_code": "07054-3707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The recall product was distributed nationwide.",
      "recall_number": "D-1145-2023",
      "product_description": "Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57",
      "product_quantity": "99,516 sachets",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.",
      "recall_initiation_date": "20230718",
      "center_classification_date": "20230906",
      "termination_date": "20260219",
      "report_date": "20230913",
      "code_info": "Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024."
    }
  ]
}