{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202359"
        ],
        "brand_name": [
          "COLISTIMETHATE SODIUM"
        ],
        "generic_name": [
          "COLISTIMETHATE SODIUM"
        ],
        "manufacturer_name": [
          "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "23155-193"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "COLISTIMETHATE SODIUM"
        ],
        "rxcui": [
          "1117522"
        ],
        "spl_id": [
          "698b0d4f-1182-475f-aafb-bfcbd0b637f2"
        ],
        "spl_set_id": [
          "6a335659-03b0-4a2d-9cd4-7dcf7da96fe6"
        ],
        "package_ndc": [
          "23155-193-41",
          "23155-193-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0323155193312"
        ],
        "unii": [
          "XW0E5YS77G"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70592",
      "recalling_firm": "Heritage Pharmaceuticals, Inc.",
      "address_1": "12 Christopher Way",
      "address_2": "Suite 300",
      "postal_code": "07724-3330",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0415-2015",
      "product_description": "Colistimethate for Injection USP, 150 mg per vial, Rx Only,  Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India  Manufactured for: Heritage Pharmaceuticals Inc.  NDC 23155-193-31",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.",
      "recall_initiation_date": "20150225",
      "center_classification_date": "20150317",
      "termination_date": "20160226",
      "report_date": "20150325",
      "code_info": "Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14  VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15,   VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16  VCOA011; Exp. 10/16",
      "more_code_info": ""
    }
  ]
}