{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA210244"
        ],
        "brand_name": [
          "GLYCOPYRROLATE"
        ],
        "generic_name": [
          "GLYCOPYRROLATE"
        ],
        "manufacturer_name": [
          "AuroMedics Pharma LLC"
        ],
        "product_ndc": [
          "55150-292",
          "55150-293",
          "55150-294",
          "55150-295"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GLYCOPYRROLATE"
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        "rxcui": [
          "238212",
          "1731582",
          "1731590"
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        "spl_id": [
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        ],
        "spl_set_id": [
          "eaebb511-1738-4d11-b9bb-317a8d41316a"
        ],
        "package_ndc": [
          "55150-292-01",
          "55150-293-02",
          "55150-294-05",
          "55150-295-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150295203"
        ],
        "unii": [
          "V92SO9WP2I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "84927",
      "recalling_firm": "AuroMedics Pharma LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Ohio, Louisiana, Mississippi",
      "recall_number": "D-0853-2020",
      "product_description": "Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.",
      "product_quantity": "4600 Vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).",
      "recall_initiation_date": "20200207",
      "center_classification_date": "20200220",
      "termination_date": "20230308",
      "report_date": "20200226",
      "code_info": "Lot #CGP190001-A, Exp. 07/31/2020",
      "more_code_info": ""
    }
  ]
}