{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079021"
        ],
        "brand_name": [
          "ATOMOXETINE"
        ],
        "generic_name": [
          "ATOMOXETINE"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-472",
          "64380-473",
          "64380-474",
          "64380-475",
          "64380-476",
          "64380-477",
          "64380-478"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "ATOMOXETINE HYDROCHLORIDE"
        ],
        "spl_id": [
          "94ef88bd-e176-4c16-9340-ae0168422053"
        ],
        "spl_set_id": [
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        "package_ndc": [
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          "64380-472-02",
          "64380-473-01",
          "64380-473-02",
          "64380-474-01",
          "64380-474-02",
          "64380-475-01",
          "64380-475-02",
          "64380-476-01",
          "64380-476-02",
          "64380-477-01",
          "64380-477-05",
          "64380-478-01",
          "64380-478-02"
        ],
        "is_original_packager": [
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        "upc": [
          "0364380475019",
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          "0364380476016",
          "0364380477013"
        ],
        "unii": [
          "57WVB6I2W0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98885",
      "recalling_firm": "Safecor Health, LLC",
      "address_1": "4060 Business Park Dr Ste B",
      "address_2": "",
      "postal_code": "43204-5047",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "TX only",
      "recall_number": "D-0538-2026",
      "product_description": "Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204.  NDC: 64380-474-01",
      "product_quantity": "149 capsules",
      "reason_for_recall": "Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.",
      "recall_initiation_date": "20260430",
      "center_classification_date": "20260518",
      "report_date": "20260527",
      "code_info": "Lot #: 25530722",
      "more_code_info": ""
    }
  ]
}