{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Coventry",
      "state": "RI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA205831"
        ],
        "brand_name": [
          "APTENSIO XR"
        ],
        "generic_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Rhodes Pharmaceuticals L.P."
        ],
        "product_ndc": [
          "42858-401",
          "42858-402",
          "42858-403",
          "42858-404",
          "42858-405",
          "42858-406",
          "42858-407"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
          "METHYLPHENIDATE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "1648183",
          "1648185",
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          "1648195",
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          "1648201",
          "1806200",
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        "spl_id": [
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        "spl_set_id": [
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          "42858-402-45",
          "42858-403-45",
          "42858-404-45",
          "42858-405-45",
          "42858-406-45",
          "42858-407-45"
        ],
        "is_original_packager": [
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        "upc": [
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          "0342858403450",
          "0342858402453",
          "0342858401456"
        ],
        "unii": [
          "4B3SC438HI"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79820",
      "recalling_firm": "Rhodes Pharmaceuticals, L.P.",
      "address_1": "498 Washington St",
      "address_2": "N/A",
      "postal_code": "02816-5467",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA",
      "recall_number": "D-0710-2018",
      "product_description": "Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45",
      "product_quantity": "2454 bottles",
      "reason_for_recall": "Failed Dissolution Specification: Low dissolution outside of specifications",
      "recall_initiation_date": "20180417",
      "center_classification_date": "20180503",
      "termination_date": "20200519",
      "report_date": "20180509",
      "code_info": "Lot# AG8679B Exp. 01/2020"
    }
  ]
}