{
  "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": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090233"
        ],
        "brand_name": [
          "BENZTROPINE MESYLATE"
        ],
        "generic_name": [
          "BENZTROPINE MESYLATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-970"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BENZTROPINE MESYLATE"
        ],
        "rxcui": [
          "885205"
        ],
        "spl_id": [
          "11222231-55b1-48ee-a8f8-3385f1a2eb36"
        ],
        "spl_set_id": [
          "b03bd28e-3b44-41e4-9a7e-28b9d7975245"
        ],
        "package_ndc": [
          "63323-970-02",
          "14789-300-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "WMJ8TL7510"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65588",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide & Puerto Rico",
      "recall_number": "D-685-2013",
      "product_description": "Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02",
      "product_quantity": "65110 vials",
      "reason_for_recall": "Presence of particulate matter:  characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials",
      "recall_initiation_date": "20130701",
      "center_classification_date": "20130705",
      "termination_date": "20151027",
      "report_date": "20130717",
      "code_info": "a) Lot: 111412, Exp: 11/2014    b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;"
    }
  ]
}