{
  "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": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213424"
        ],
        "brand_name": [
          "ATROPINE SULFATE"
        ],
        "generic_name": [
          "ATROPINE SULFATE"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-512"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ENDOTRACHEAL",
          "INTRAMEDULLARY",
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ATROPINE SULFATE"
        ],
        "rxcui": [
          "1190776"
        ],
        "spl_id": [
          "275def6c-5b2d-918b-e063-6294a90aa71f"
        ],
        "spl_set_id": [
          "f3cb74e9-b4ac-4efe-bd8e-8a71970ee7c7"
        ],
        "package_ndc": [
          "16729-512-05",
          "16729-512-43"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729512053"
        ],
        "unii": [
          "03J5ZE7KA5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92639",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0917-2023",
      "product_description": "Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials,  Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.",
      "product_quantity": "2348 vials",
      "reason_for_recall": "Presence of Particulate Matter: Particulate matter identified as fiber.",
      "recall_initiation_date": "20230703",
      "center_classification_date": "20230713",
      "termination_date": "20241017",
      "report_date": "20230719",
      "code_info": "Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025",
      "more_code_info": ""
    }
  ]
}