{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Weston",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078479"
        ],
        "brand_name": [
          "BRIMONIDINE TARTRATE"
        ],
        "generic_name": [
          "BRIMONIDINE TARTRATE"
        ],
        "manufacturer_name": [
          "Apotex Corp."
        ],
        "product_ndc": [
          "60505-0564"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BRIMONIDINE TARTRATE"
        ],
        "rxcui": [
          "861208"
        ],
        "spl_id": [
          "5832760f-7397-35f8-6aa8-abdaebbe657a"
        ],
        "spl_set_id": [
          "64b21e68-610c-5194-ccb2-9d9f6ff8cda9"
        ],
        "package_ndc": [
          "60505-0564-1",
          "60505-0564-2",
          "60505-0564-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4S9CL2DY2H"
        ],
        "upc": [
          "360505056415",
          "360505056422",
          "360505056439"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91803",
      "recalling_firm": "Apotex Corp.",
      "address_1": "2400 N Commerce Pkwy Ste 400",
      "address_2": "",
      "postal_code": "33326-3253",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0433-2023",
      "product_description": "Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326",
      "product_quantity": "67,056 bottles",
      "reason_for_recall": "Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.",
      "recall_initiation_date": "20230301",
      "center_classification_date": "20230303",
      "report_date": "20230315",
      "code_info": "Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024",
      "more_code_info": ""
    }
  ]
}