{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205063"
        ],
        "brand_name": [
          "ISOTRETINOIN"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2433",
          "0591-2434",
          "0591-2451",
          "0591-2435",
          "0591-2501",
          "0591-2436"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
          "197843",
          "197844",
          "197845",
          "403930",
          "1547561",
          "1547565"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0591-2433-45",
          "0591-2433-15",
          "0591-2434-45",
          "0591-2434-15",
          "0591-2451-45",
          "0591-2451-15",
          "0591-2435-45",
          "0591-2435-15",
          "0591-2501-45",
          "0591-2501-15",
          "0591-2436-45",
          "0591-2436-15"
        ],
        "is_original_packager": [
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        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98275",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, OH, PR & MS",
      "recall_number": "D-0446-2026",
      "product_description": "Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).",
      "product_quantity": "8376 packages",
      "reason_for_recall": "Superpotent and Subpotent",
      "recall_initiation_date": "20260112",
      "center_classification_date": "20260408",
      "report_date": "20260415",
      "code_info": "Lots 100075305  Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .",
      "more_code_info": ""
    }
  ]
}