{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA211644"
        ],
        "brand_name": [
          "TRETINOIN"
        ],
        "generic_name": [
          "TRETINOIN"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "16714-249"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TRETINOIN"
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        "rxcui": [
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        ],
        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "16714-249-01",
          "16714-249-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "5688UTC01R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99977",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0034-2027",
      "product_description": "Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20260925",
      "center_classification_date": "20261008",
      "report_date": "20261014",
      "code_info": "Lot # AD96183, Exp Date: 12/31/2026."
    }
  ]
}