{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091157"
        ],
        "brand_name": [
          "PREGABALIN"
        ],
        "generic_name": [
          "PREGABALIN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-686",
          "47335-687",
          "47335-688",
          "47335-689",
          "47335-690",
          "47335-691",
          "47335-692",
          "47335-693"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PREGABALIN"
        ],
        "rxcui": [
          "483438",
          "483440",
          "483442",
          "483444",
          "483446",
          "483448",
          "483450",
          "577127"
        ],
        "spl_id": [
          "52bb3d43-24c1-4789-8423-6c2d54850e75"
        ],
        "spl_set_id": [
          "ee7b9119-e88f-48ad-ae97-55e53374e62f"
        ],
        "package_ndc": [
          "47335-686-83",
          "47335-686-88",
          "47335-686-08",
          "47335-686-18",
          "47335-687-83",
          "47335-687-88",
          "47335-687-08",
          "47335-687-18",
          "47335-688-83",
          "47335-688-88",
          "47335-688-08",
          "47335-688-18",
          "47335-689-83",
          "47335-689-88",
          "47335-689-08",
          "47335-689-18",
          "47335-690-83",
          "47335-690-88",
          "47335-690-08",
          "47335-690-18",
          "47335-691-83",
          "47335-691-88",
          "47335-691-08",
          "47335-691-18",
          "47335-692-83",
          "47335-692-88",
          "47335-692-08",
          "47335-692-18",
          "47335-693-83",
          "47335-693-88",
          "47335-693-08",
          "47335-693-18"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0347335692884",
          "0347335693881",
          "0347335688887",
          "0347335689884",
          "0347335686883",
          "0347335687880",
          "0347335691887",
          "0347335690880"
        ],
        "unii": [
          "55JG375S6M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88927",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0361-2022",
      "product_description": "Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.",
      "product_quantity": "696 Bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.",
      "recall_initiation_date": "20211022",
      "center_classification_date": "20220106",
      "termination_date": "20230406",
      "report_date": "20220112",
      "code_info": "Lot number: DNC0432A, expiration 01/2023"
    }
  ]
}