{
  "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": "Waterford",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "79149",
      "recalling_firm": "American Pharmaceutical Ingredients LLC",
      "address_1": "6650 Highland Rd Ste 302",
      "address_2": "N/A",
      "postal_code": "48327-1665",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within USA.",
      "recall_number": "D-0533-2018",
      "product_description": "Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327",
      "product_quantity": "10000 g",
      "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.",
      "recall_initiation_date": "20180209",
      "center_classification_date": "20180222",
      "termination_date": "20191202",
      "report_date": "20180228",
      "code_info": "Lot #: a) 070717-2, Exp. 05/31/2020; b)  070717-1, Exp. 05/31/2020; c)  070717-1, Exp. 05/31/2020; d)  070717-1, Exp. 05/31/2020."
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}