{
  "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
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075945"
        ],
        "brand_name": [
          "AMNESTEEM"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-6611",
          "0378-6612",
          "0378-6613",
          "0378-6614"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
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          "197844",
          "197845",
          "403930",
          "404058",
          "404061",
          "404064",
          "2711694"
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        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0378-6611-85",
          "0378-6611-93",
          "0378-6612-85",
          "0378-6612-93",
          "0378-6613-85",
          "0378-6613-93",
          "0378-6614-85",
          "0378-6614-93"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175607",
          "M0018962"
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        "pharm_class_epc": [
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        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98477",
      "recalling_firm": "MYLAN PHARMACEUTICALS INC",
      "address_1": "1311 Pineview Dr",
      "address_2": "N/A",
      "postal_code": "26505-3276",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0399-2026",
      "product_description": "Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.",
      "product_quantity": "34850 blister packs",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20260224",
      "center_classification_date": "20260319",
      "report_date": "20260311",
      "code_info": "Lot #: 3116110, 3116130, Exp. Date 07/2026"
    }
  ]
}