{
  "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
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  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hauppauge",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "81458",
      "recalling_firm": "Sciegen Pharmaceuticals Inc",
      "address_1": "89 Arkay Dr",
      "address_2": "N/A",
      "postal_code": "11788-3727",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0271-2019",
      "product_description": "GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.",
      "product_quantity": "18,760 HDPE bottles",
      "reason_for_recall": "CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.",
      "recall_initiation_date": "20181029",
      "center_classification_date": "20181120",
      "termination_date": "20230925",
      "report_date": "20181128",
      "code_info": "60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle    B161003 Sep-19   B161004 Sep-19   B161006 Sep-19   B161007 Sep-19   B161008 Nov-19   B161009 Nov-19   B161010 Nov-19   C161001 Feb-20   C161003 May-20           60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle   GS019526 Nov-19   GS020252 Nov-19   GS020958 Nov-19",
      "more_code_info": ""
    }
  ]
}