{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "status": "Terminated",
      "city": "La Vergne",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "96105",
      "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
      "address_1": "341 Mason Rd",
      "address_2": "",
      "postal_code": "37086-3606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0212-2025",
      "product_description": "Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.",
      "product_quantity": "a) 6408 boxes and b)1488 boxes",
      "reason_for_recall": "CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit",
      "recall_initiation_date": "20250113",
      "center_classification_date": "20250129",
      "termination_date": "20260305",
      "report_date": "20250205",
      "code_info": "Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025",
      "more_code_info": ""
    }
  ]
}