{
  "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": "Sellersville",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA079031"
        ],
        "brand_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-5346",
          "0093-5347",
          "0093-5348"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1806177",
          "1806179",
          "1806183"
        ],
        "spl_id": [
          "663ba889-95b5-45c2-af06-c90459d30d6d"
        ],
        "spl_set_id": [
          "034fb7cd-e183-475e-8beb-64fd88facc8f"
        ],
        "package_ndc": [
          "0093-5346-01",
          "0093-5347-01",
          "0093-5348-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4B3SC438HI"
        ],
        "upc": [
          "009353460134"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65515",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc.",
      "address_1": "650 Cathill Rd",
      "address_2": "N/A",
      "postal_code": "18960-1512",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-847-2013",
      "product_description": "Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01",
      "product_quantity": "16,293 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.",
      "recall_initiation_date": "20130618",
      "center_classification_date": "20130807",
      "termination_date": "20140827",
      "report_date": "20130814",
      "code_info": "34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14."
    }
  ]
}