{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA203602"
        ],
        "brand_name": [
          "MORPHINE SULFATE"
        ],
        "generic_name": [
          "MORPHINE SULFATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-540",
          "43386-541",
          "43386-542",
          "43386-543",
          "43386-544"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "891874",
          "891881",
          "891888",
          "891893",
          "892646"
        ],
        "spl_id": [
          "d4efe614-fe99-4cc7-b3ba-87c4e010efbd"
        ],
        "spl_set_id": [
          "d360a33f-6323-4b10-9e81-07e2813c2dbd"
        ],
        "package_ndc": [
          "43386-540-01",
          "43386-540-05",
          "43386-541-01",
          "43386-541-05",
          "43386-542-01",
          "43386-542-05",
          "43386-543-01",
          "43386-543-05",
          "43386-544-01",
          "43386-544-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343386542017",
          "0343386543014",
          "0343386540013",
          "0343386541010"
        ],
        "unii": [
          "X3P646A2J0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80874",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-1214-2018",
      "product_description": "Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01",
      "product_quantity": "4716 bottle",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.",
      "recall_initiation_date": "20180823",
      "center_classification_date": "20180927",
      "termination_date": "20221014",
      "report_date": "20180926",
      "code_info": "Lot# S800232, Exp 2/20"
    }
  ]
}