Events

Recall of GSK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GSK Consumer Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74030
  • Event Risk Class
    Class 3
  • Event Number
    Z-2148-2016
  • Event Initiated Date
    2016-04-25
  • Event Date Posted
    2016-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146010
  • Notes / Alerts
    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.
  • Extra notes in the data
    Breathing - Nasal Strips - Product Code N/A
  • Reason
    Some cartons used in the secondary packaging of breathe right clear, large, 30 ct. nasal strips were incorrectly labeled for cartons intended for the au/nz market.
  • Action
    GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.

Device

GSK
  • Model / Serial
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • Distribution
    US Nationwide
  • Product Description
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer
    GSK Consumer Healthcare

Manufacturer

GSK Consumer Healthcare
  • Manufacturer Address
    GSK Consumer Healthcare, 184 Liberty Corner Rd Ste 200, Warren NJ 07059-6868
  • Manufacturer Parent Company (2017)
    Glaxosmithkline Plc
  • Source
    USFDA