Biotene Moisturizing Mouth Spray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GlaxoSmithKline, LLC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    66689
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0272-2014
  • 사례 시작날짜
    2013-10-17
  • 사례 출판 날짜
    2013-11-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-07-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Saliva, artificial - Product Code LFD
  • 원인
    Label indicates, "sweetened with xylitol and sorbitol", however product does not contain sorbitol.
  • 조치
    GlaxoSmithKline sent an Urgent Medical Device Recall letter dated October 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product. If product was further distributed customers were instructed notify their customers of the recall and the actions required. Customers were asked to complete and return the enclosed business replay card even if they have no affected product in their inventory. Customers should complete the return goods packing slip, enclose it with their return goods shipment and affix the return label to the package. Customers with questions should call Customers Service at 1-800-743-4014. For questions regarding this recall call 919-269-1194.

Device

  • 모델명 / 제조번호(시리얼번호)
    UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution .
  • 제품 설명
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. || Biotene Mouth Spray is used for the treatment of dry mouth
  • Manufacturer

Manufacturer

  • 제조사 주소
    GlaxoSmithKline, LLC., 1011 North Arendell Ave, Zebulon NC 27597-1217
  • 제조사 모회사 (2017)
  • Source
    USFDA