{
  "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": "Sellersville",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA065056"
        ],
        "brand_name": [
          "AMOXICILLIN"
        ],
        "generic_name": [
          "AMOXICILLIN"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-2263",
          "0093-2264",
          "0093-4160",
          "0093-4155",
          "0093-4161",
          "0093-2267",
          "0093-2268",
          "0093-3107",
          "0093-3109"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMOXICILLIN"
        ],
        "rxcui": [
          "239191",
          "308177",
          "308182",
          "308189",
          "308191",
          "308192",
          "308194",
          "313850",
          "598025"
        ],
        "spl_id": [
          "31223839-1653-4906-826a-f9d6af179334"
        ],
        "spl_set_id": [
          "4c0f348a-a65d-409c-8668-207c82a5e3cb"
        ],
        "package_ndc": [
          "0093-2263-01",
          "0093-2264-01",
          "0093-4160-76",
          "0093-4160-78",
          "0093-4160-73",
          "0093-4155-79",
          "0093-4155-73",
          "0093-4155-80",
          "0093-4161-76",
          "0093-4161-78",
          "0093-4161-73",
          "0093-2267-01",
          "0093-2268-01",
          "0093-3107-01",
          "0093-3107-05",
          "0093-3109-53",
          "0093-3109-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300933107051",
          "0300932264014",
          "0300934161731",
          "0300933109055",
          "0300932267015",
          "0300932268012",
          "0300932263017",
          "0300934160734",
          "0300934155730"
        ],
        "unii": [
          "804826J2HU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65050",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc.",
      "address_1": "650 Cathill Rd",
      "address_2": "N/A",
      "postal_code": "18960-1512",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-598-2013",
      "product_description": "Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)",
      "product_quantity": "758,554 bottles",
      "reason_for_recall": "Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.",
      "recall_initiation_date": "20130426",
      "center_classification_date": "20130611",
      "termination_date": "20131224",
      "report_date": "20130619",
      "code_info": "a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and   b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014."
    }
  ]
}