{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dawsonville",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "97251",
      "recalling_firm": "Direct Rx",
      "address_1": "94 Worldwide Dr",
      "address_2": "N/A",
      "postal_code": "30534-6828",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0568-2025",
      "product_description": "Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90;   Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,",
      "product_quantity": "875 bottles",
      "reason_for_recall": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.",
      "recall_initiation_date": "20250307",
      "center_classification_date": "20250804",
      "report_date": "20250813",
      "code_info": "Lot #:  a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027;  c) 23AU2317, 21AU2314, Exp 01/31/2026.",
      "more_code_info": ""
    }
  ]
}