{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA206674"
        ],
        "brand_name": [
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        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "69097-878",
          "69097-879"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        "substance_name": [
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        "rxcui": [
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        "spl_id": [
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        "package_ndc": [
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          "69097-877-03",
          "69097-877-07",
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          "69097-878-02",
          "69097-878-03",
          "69097-878-07",
          "69097-878-12",
          "69097-879-02",
          "69097-879-03",
          "69097-879-07",
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        ],
        "is_original_packager": [
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        "upc": [
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          "0369097878030",
          "0369097877033"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79446",
      "recalling_firm": "InvaGen Pharmaceuticals, Inc.",
      "address_1": "7 Oser Ave",
      "address_2": "N/A",
      "postal_code": "11788-3811",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0619-2018",
      "product_description": "buPROPion HCl Extended-Release Tablets,   USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03)  and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Dissolution Specifications; during stability testing",
      "recall_initiation_date": "20180315",
      "center_classification_date": "20180404",
      "termination_date": "20210915",
      "report_date": "20180411",
      "code_info": "a)   Lot I1606609 and Lot I1606610 Exp. Date 05/2018;  Lot I1610639 Exp. Date 09/2018    b)   Lot #I1606610 Exp Date 05/2018;  Lot I1607847 and Lot I1607845 Exp Date 06/2018;  Lot I1610639 Exp Date 09/2018"
    }
  ]
}