{
  "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": [
          "NDA020622"
        ],
        "brand_name": [
          "COPAXONE"
        ],
        "generic_name": [
          "GLATIRAMER ACETATE"
        ],
        "manufacturer_name": [
          "Teva Neuroscience, Inc."
        ],
        "product_ndc": [
          "68546-317",
          "68546-325"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "GLATIRAMER ACETATE"
        ],
        "rxcui": [
          "1111641",
          "1111642",
          "1487361",
          "1487363"
        ],
        "spl_id": [
          "5a691b1f-367f-4635-a7d6-0111361a2dbb"
        ],
        "spl_set_id": [
          "aa88f583-4f5f-433b-80b4-1f4c9fb28357"
        ],
        "package_ndc": [
          "68546-317-00",
          "68546-317-30",
          "68546-325-06",
          "68546-325-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5M691HL4BO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63819",
      "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-249-2013",
      "product_description": "Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO  64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 68546-317-30",
      "product_quantity": "6,692 boxes",
      "reason_for_recall": "Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.",
      "recall_initiation_date": "20121205",
      "center_classification_date": "20130412",
      "termination_date": "20130705",
      "report_date": "20130424",
      "code_info": "Lot P53847, Exp 01/14"
    }
  ]
}