{
  "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": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": "93816",
      "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": "Nationwide in the USA",
      "recall_number": "D-0339-2024",
      "product_description": "Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), 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": "71,244 sachets",
      "reason_for_recall": "Failed Impurities/Degradation Specification: Out of specification for organic impurities",
      "recall_initiation_date": "20240116",
      "center_classification_date": "20240220",
      "report_date": "20240228",
      "code_info": "lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024."
    }
  ]
}