{
  "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": "65516",
      "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-803-2013",
      "product_description": "Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only,  Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.",
      "product_quantity": "109,080 Bottles",
      "reason_for_recall": "Discoloration:  This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.",
      "recall_initiation_date": "20130618",
      "center_classification_date": "20130717",
      "termination_date": "20131224",
      "report_date": "20130724",
      "code_info": "Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14"
    }
  ]
}