{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091023"
        ],
        "brand_name": [
          "CLOPIDOGREL BISULFATE"
        ],
        "generic_name": [
          "CLOPIDOGREL BISULFATE"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-671"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLOPIDOGREL BISULFATE"
        ],
        "rxcui": [
          "749196"
        ],
        "spl_id": [
          "e74780f8-a035-e6a0-b457-c04edd4162bf"
        ],
        "spl_set_id": [
          "4da4da53-91ae-4d4f-145f-255c5db443a5"
        ],
        "package_ndc": [
          "55111-671-30",
          "55111-671-90",
          "55111-671-01",
          "55111-671-05",
          "55111-671-48",
          "55111-671-79",
          "55111-671-81",
          "55111-671-06",
          "55111-671-31",
          "55111-671-78"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "08I79HTP27"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81530",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A.nationwide",
      "recall_number": "D-0283-2019",
      "product_description": "Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31",
      "product_quantity": "4,212 (30-count blister pack)",
      "reason_for_recall": "Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.",
      "recall_initiation_date": "20181107",
      "center_classification_date": "20181127",
      "termination_date": "20200519",
      "report_date": "20181128",
      "code_info": "Lot #: T600530, Exp 11/18",
      "more_code_info": ""
    }
  ]
}