BEUDAMED
    FDA Recall Terminated

    CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). [OTC] Item Number: 191648

    Recall: Z-0379-04 · Initiated November 20, 2003

    Recall

    Recall Number
    Z-0379-04
    Event Number
    28079
    FEI Number
    1217081
    Product Code
    LYL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 20, 2003
    Posted
    July 20, 2004
    Terminated
    April 6, 2004
    Address
    CVS 1 CVS Drive, Woonsocket, RI, 02895-6146

    Description

    CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). [OTC] Item Number: 191648

    Reason

    Product label fails to provide adequate warning for use

    Action

    CVS issued a product recall on 11/19/03, from the Category Manager to Store Operations for the product to be removed from retail stores. The request listed Item # 191648, CVS One-Step Disinfecting Solution, 12 fl. oz., all lot #''s,.Individual pieces (bottles) would be returned through a third party, Carolina Logistics. An e-mail was also sent on 11/19/03 from the Quality Assurance Department to the nine CVS distribution centers requesting item # 191648 be removed from its pick line location as well as any other warehouse locations and be put on quality hold. Each distribution center was asked to return the amount of product on hand at that particular center to the quality assurance department. The product was removed from sale from the CVS.com website.

    Distribution

    Nationwide

    Quantity

    19, 261 units