{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "PHENOBARBITAL SODIUM"
        ],
        "generic_name": [
          "PHENOBARBITAL SODIUM"
        ],
        "manufacturer_name": [
          "Cameron Pharmaceuticals"
        ],
        "product_ndc": [
          "42494-415",
          "42494-416"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "PHENOBARBITAL SODIUM"
        ],
        "rxcui": [
          "2671204",
          "2671207"
        ],
        "spl_id": [
          "f69a86e8-b217-47eb-b536-2b5677cfe85f"
        ],
        "spl_set_id": [
          "50e73787-ede1-4839-aaa5-806e25f18b1a"
        ],
        "package_ndc": [
          "42494-416-25",
          "42494-416-03",
          "42494-415-25",
          "42494-415-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SW9M9BB5K3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89803",
      "recalling_firm": "Vitae Enim Vitae Scientific, Inc.",
      "address_1": "3030 Bunker Hill St Ste 203",
      "address_2": "",
      "postal_code": "92109-5754",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the U.S.A",
      "recall_number": "D-0744-2022",
      "product_description": "PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.",
      "product_quantity": "a) 18,531 boxes; b) 4,492 boxes",
      "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.",
      "recall_initiation_date": "20220314",
      "center_classification_date": "20220405",
      "termination_date": "20240815",
      "report_date": "20220413",
      "code_info": "Lot # a) 20VPSI011, Exp. 4/30/2022; 20VPSI014, Exp. 5/31/2022; 20VPSI020, 20VPSI022, 20VPSI023, Exp. 7/31/2022; 21VPSI007, Exp. 3/31/2023; 21VPSI013, Exp. 5/31/2023; 21VPSI027, Exp. 6/30/2023; 21VPSI039, Exp. 8/31/2023; 21VPSI042, Exp. 10/31/2023; 21VPSI049, Exp. 11/30/2023; 21VPSI052, Exp. 12/31/2023; 22VPSI005, Exp. 7/31/2024; 22VPSI007, Exp. 8/31/2024; Lots: b) 22VPSI007, Exp. 8/31/2024; 20VPSI009, Exp. 3/31/2022; 20VPSI020, Exp. 7/31/2022; 21VPSI039, Exp. 8/31/2023; 22VPSI005, Exp. 7/31/2024.",
      "more_code_info": ""
    }
  ]
}