{
  "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": [
          "ANDA091528"
        ],
        "brand_name": [
          "HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"
        ],
        "generic_name": [
          "HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-118"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HOMATROPINE METHYLBROMIDE",
          "HYDROCODONE BITARTRATE"
        ],
        "rxcui": [
          "992656"
        ],
        "spl_id": [
          "116df522-26b7-42de-8c0b-16cc60c2e764"
        ],
        "spl_set_id": [
          "41ac90b3-f007-4eb2-9d41-ea626ced2017"
        ],
        "package_ndc": [
          "43386-118-03",
          "43386-118-01",
          "43386-118-05",
          "3433861180"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343386118038",
          "343386118038"
        ],
        "unii": [
          "68JRS2HC1C",
          "NO70W886KK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79298",
      "recalling_firm": "Novel Laboratories, Inc.",
      "address_1": "400 Campus Dr",
      "address_2": "",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0599-2018",
      "product_description": "Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202   NDC 43386-118-03  UPC 343386118038",
      "product_quantity": "134,364 bottles (4,030,920 tablets)",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20180305",
      "center_classification_date": "20180314",
      "termination_date": "20200608",
      "report_date": "20180321",
      "code_info": "M16002A (02/2018);   M16246A (04/2018);   M16246B (04/2018);   M16434A (07/2018);   M16569A (10/2018);   M17015A (01/2019);   S700271 (04/2019);",
      "more_code_info": ""
    }
  ]
}