{
  "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,
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    }
  },
  "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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        ],
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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": "94294",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0439-2024",
      "product_description": "Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only,  Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054.  Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15",
      "product_quantity": "5,304 3x10-cartons",
      "reason_for_recall": "Superpotent Drug: The 3-month stability result for assay was found to be above specification limit",
      "recall_initiation_date": "20240328",
      "center_classification_date": "20240408",
      "report_date": "20240417",
      "code_info": "Lot #: 100044259, Exp 06/30/2025."
    }
  ]
}