BEUDAMED
    FDA Recall Terminated

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    Recall: Z-0873-2013 · Initiated January 25, 2013

    Recall

    Recall Number
    Z-0873-2013
    Event Number
    64322
    Firm
    Mc-NEIL-PPC, Inc.
    FEI Number
    2214133
    Product Code
    NUC
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 25, 2013
    Posted
    February 22, 2013
    Terminated
    April 11, 2014
    Address
    199 Grandview Rd, Skillman, NJ, 08558-1311

    Description

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    Reason

    This product is not cleared for marketing in the US.

    Action

    Johnson and Johnson Healthcare Products sent recall notification letters dated 1/25/2013 to its customers (retailers and wholesalers). The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to return all cases of affected product in their possession. The letter included delivery confirmation and a return packing slip, return authorization label and business reply card. Contact J & J Sales & Logistics at 866-912-8414 for questions regarding the return of affected product. Contact your J & J Sales & Logistics Company Sales Representative for questions about the product.

    Distribution

    Nationwide Distribution.

    Quantity

    1,185,664 units