{
  "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": "Suffern",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA010187"
        ],
        "brand_name": [
          "RITALIN"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0439",
          "0078-0440",
          "0078-0441"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1091150",
          "1091379",
          "1091392",
          "1091395",
          "1091497",
          "1091500"
        ],
        "spl_id": [
          "00db4d6e-410b-43a1-ab5e-7047f525e68d"
        ],
        "spl_set_id": [
          "c0bf0835-6a2f-4067-a158-8b86c4b0668a"
        ],
        "package_ndc": [
          "0078-0439-05",
          "0078-0440-05",
          "0078-0441-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300780441056",
          "0300780439053"
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67633",
      "recalling_firm": "Novartis Pharmaceuticals Corp.",
      "address_1": "25 Old Mill Rd",
      "address_2": "N/A",
      "postal_code": "10901-4106",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1228-2014",
      "product_description": "Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901  Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05",
      "product_quantity": "10,781 bottles",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets.  Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert.  The individual Medication Guides are attached to the Package Insert via a perforation.  Although t",
      "recall_initiation_date": "20140303",
      "center_classification_date": "20140408",
      "termination_date": "20141202",
      "report_date": "20140416",
      "code_info": "Lot #: F0131"
    }
  ]
}