{
  "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": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA215338"
        ],
        "brand_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "69238-2261"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "2000134"
        ],
        "spl_id": [
          "71d25621-053b-45e0-a795-60d19aa5effa"
        ],
        "spl_set_id": [
          "3c47d5c4-8cdb-4701-8d7a-8a6e79025b53"
        ],
        "package_ndc": [
          "69238-2261-3",
          "69238-2261-7",
          "69238-2261-5"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369238226133",
          "0369238226157",
          "0369238226171"
        ],
        "unii": [
          "71WO621TJD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94262",
      "recalling_firm": "Amneal Pharmaceuticals of New York, LLC",
      "address_1": "50 Horseblock Rd",
      "address_2": "",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0442-2024",
      "product_description": "Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle,  NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807",
      "product_quantity": "821 bottles",
      "reason_for_recall": "Superpotent Drug:  Due to overfilling of drug powder",
      "recall_initiation_date": "20240321",
      "center_classification_date": "20240412",
      "termination_date": "20250721",
      "report_date": "20240424",
      "code_info": "Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025",
      "more_code_info": ""
    }
  ]
}