{
  "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": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA206556"
        ],
        "brand_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "CIPLA USA INC.,"
        ],
        "product_ndc": [
          "69097-875",
          "69097-876"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BUPROPION HYDROCHLORIDE"
        ],
        "rxcui": [
          "993541",
          "993557"
        ],
        "spl_id": [
          "6fb20e45-74e9-4038-9db0-9eaf24b5560a"
        ],
        "spl_set_id": [
          "c2cf79d7-1aba-4391-980b-5e218781f7c6"
        ],
        "package_ndc": [
          "69097-875-02",
          "69097-875-05",
          "69097-875-12",
          "69097-876-02",
          "69097-876-12",
          "68001-322-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369097875022",
          "0369097876029"
        ],
        "unii": [
          "ZG7E5POY8O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80973",
      "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": "Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.",
      "recall_number": "D-1212-2018",
      "product_description": "Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788",
      "product_quantity": "26,496 bottles",
      "reason_for_recall": "Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.",
      "recall_initiation_date": "20180906",
      "center_classification_date": "20180925",
      "termination_date": "20201022",
      "report_date": "20180926",
      "code_info": "Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20"
    }
  ]
}