BEUDAMED
    FDA Recall Terminated

    Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''

    Recall: Z-0045-2007 · Initiated August 2, 2006

    Recall

    Recall Number
    Z-0045-2007
    Event Number
    36103
    Firm
    Eatonform Inc
    FEI Number
    3005029365
    Product Code
    NXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2006
    Posted
    October 19, 2006
    Terminated
    May 21, 2012
    Address
    2280 Arbor Blvd, Dayton, OH, 45439-1522

    Description

    Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''

    Reason

    Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.

    Action

    The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 8/2/2006, 8/4/2006, and 8/11/2006. In their recall notifications, the firm requested that the pharmacy customers: 1) cease using and distributing all Doc-U-Dose packets identified with the recalled lot numbers; 2) segregate and secure all Doc-U-Dose packets identified with the suspect lot numbers on-hand; 3) inform the firm as to whether or not they have any of the suspect product which they would be returning and the quantity of product to be returned; 4) return all packets to Eatonform at the recalling firms expense; and 5) notify their subaccount customers and ask that they cease using the device until such time as the problem is corrected.

    Distribution

    Nationwide

    Quantity

    approximately 913 cartons