BEUDAMED
    FDA Recall Terminated

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    Recall: Z-2148-2016 · Initiated April 25, 2016

    Recall

    Recall Number
    Z-2148-2016
    Event Number
    74030
    Firm
    GSK Consumer Healthcare
    FEI Number
    3012293198
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 25, 2016
    Posted
    July 11, 2016
    Terminated
    July 19, 2017
    Address
    184 Liberty Corner Rd, Ste 200, Warren, NJ, 07059-6868

    Description

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    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.

    Distribution

    US Nationwide

    Quantity

    1,440 cases ( 34, 560 retail - units )