{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA216605"
        ],
        "brand_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "70121-1732",
          "70121-1733",
          "70121-1734",
          "70121-1735"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INFILTRATION",
          "PERINEURAL"
        ],
        "substance_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1734347",
          "1734355",
          "1734479",
          "1734481"
        ],
        "spl_id": [
          "aa7176ac-f262-4470-a4de-60e288c05ac3"
        ],
        "spl_set_id": [
          "da1ce22b-6a8e-40a2-afbb-011fa3ed3a8b"
        ],
        "package_ndc": [
          "70121-1732-9",
          "70121-1732-3",
          "70121-1733-9",
          "70121-1733-3",
          "70121-1734-7",
          "70121-1734-3",
          "70121-1735-7",
          "70121-1735-3",
          "70121-1734-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370121173533",
          "0370121173434",
          "0370121173335",
          "0370121173311",
          "0370121173410",
          "0370121173519",
          "0370121173397",
          "0370121173298",
          "0370121173212"
        ],
        "unii": [
          "V910P86109"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96648",
      "recalling_firm": "Amneal Pharmaceuticals, LLC",
      "address_1": "400 Crossing Blvd Fl 3",
      "address_2": "N/A",
      "postal_code": "08807-2863",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0402-2025",
      "product_description": "Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India,  , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)",
      "product_quantity": "62 (12x100mL) bags",
      "reason_for_recall": "Presence of Particulate Matter",
      "recall_initiation_date": "20250417",
      "center_classification_date": "20250505",
      "report_date": "20250514",
      "code_info": "Lot #'s: AL240003, AL240004, Exp.: 01/31/2026",
      "more_code_info": ""
    }
  ]
}