{
  "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 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-0272-2019",
      "product_description": "GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.",
      "product_quantity": "30,194 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": "60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19   GS019073 Sep-19   GS021472 Nov-19   GS021530 Nov-19   GS022234 Feb-20         60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19   B162010 Sep-19   B162011 Sep-19   B162012 Nov-19   B162013 Nov-19   B162014 Nov-19   B162015 Nov-19   C162001 Feb-20",
      "more_code_info": ""
    }
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}