{
  "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": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202800"
        ],
        "brand_name": [
          "ACETAMINOPHEN AND CODEINE PHOSPHATE"
        ],
        "generic_name": [
          "ACETAMINOPHEN AND CODEINE PHOSPHATE"
        ],
        "manufacturer_name": [
          "Aurolife Pharma, LLC"
        ],
        "product_ndc": [
          "13107-058",
          "13107-059",
          "13107-060"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "CODEINE PHOSPHATE"
        ],
        "rxcui": [
          "993770",
          "993781",
          "993890"
        ],
        "spl_id": [
          "d0765823-c018-4aae-85e9-27288fe43950"
        ],
        "spl_set_id": [
          "02386806-02d4-47e3-9c8b-7810146ee795"
        ],
        "package_ndc": [
          "13107-058-30",
          "13107-058-01",
          "13107-058-05",
          "13107-058-99",
          "13107-059-30",
          "13107-059-01",
          "13107-059-05",
          "13107-059-99",
          "13107-060-30",
          "13107-060-01",
          "13107-060-05",
          "13107-060-99"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0313107058011"
        ],
        "unii": [
          "GSL05Y1MN6",
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79961",
      "recalling_firm": "Prescript Pharmaceuticals, Inc.",
      "address_1": "39 California Ave Ste 104",
      "address_2": "",
      "postal_code": "94566-6279",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "California.",
      "recall_number": "D-0806-2018",
      "product_description": "Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033",
      "product_quantity": "1 20-count containers",
      "reason_for_recall": "Labeling: Not Elsewhere Classified:  due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).",
      "recall_initiation_date": "20180424",
      "center_classification_date": "20180514",
      "termination_date": "20190123",
      "report_date": "20180523",
      "code_info": "Lot # 0130131, EXP 8/31/20",
      "more_code_info": ""
    }
  ]
}