{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cranbury",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "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",
          "2262729",
          "2262731"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "3ef0cff8-19c1-4441-b780-fca6c7ee1615"
        ],
        "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",
          "10631-133-69",
          "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",
          "3106311173"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "EH28UP18IF"
        ],
        "upc": [
          "310631117313"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81765",
      "recalling_firm": "Sun Pharmaceutical Industries, Inc.",
      "address_1": "270 Prospect Plains Rd",
      "address_2": "",
      "postal_code": "08512-3605",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1207-2019",
      "product_description": "Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs)  Rx only, Manufactured by:  Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton)  NDC10631-117-69 (prescription pack)",
      "product_quantity": "47,520 prescription packs",
      "reason_for_recall": "Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.",
      "recall_initiation_date": "20181207",
      "center_classification_date": "20190422",
      "termination_date": "20190614",
      "report_date": "20181226",
      "code_info": "Lot: 17F28AA, Exp 1/2020",
      "more_code_info": ""
    }
  ]
}