{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA211913"
        ],
        "brand_name": [
          "ABSORICA LD"
        ],
        "generic_name": [
          "ISOTRETINOIN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "10631-002",
          "10631-115",
          "10631-116",
          "10631-117",
          "10631-118",
          "10631-133",
          "10631-134",
          "10631-003",
          "10631-004",
          "10631-005",
          "10631-006",
          "10631-007"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ISOTRETINOIN"
        ],
        "rxcui": [
          "197843",
          "197844",
          "197845",
          "403930",
          "1299203",
          "1300006",
          "1300014",
          "1300016",
          "1547561",
          "1547563",
          "1547565",
          "1547567",
          "2262711",
          "2262713",
          "2262714",
          "2262715",
          "2262717",
          "2262719",
          "2262721",
          "2262723",
          "2262725",
          "2262727",
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          "2262731"
        ],
        "spl_id": [
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        ],
        "package_ndc": [
          "10631-115-69",
          "10631-115-31",
          "10631-116-69",
          "10631-116-31",
          "10631-117-69",
          "10631-117-31",
          "10631-118-69",
          "10631-118-31",
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          "10631-133-31",
          "10631-134-69",
          "10631-134-31",
          "10631-002-31",
          "10631-003-31",
          "10631-004-31",
          "10631-005-31",
          "10631-006-31",
          "10631-007-31"
        ],
        "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": "71865",
      "recalling_firm": "Ranbaxy Inc.",
      "address_1": "600 College Rd E Ste 2100",
      "address_2": "N/A",
      "postal_code": "08540-6636",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1288-2015",
      "product_description": "Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only.  Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.",
      "product_quantity": "9,229 Boxes",
      "reason_for_recall": "Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.",
      "recall_initiation_date": "20150626",
      "center_classification_date": "20150806",
      "termination_date": "20160429",
      "report_date": "20150812",
      "code_info": "Lot #:14H04AA, Expiry: 02/28/2017."
    }
  ]
}