BEUDAMED
    FDA Recall Terminated

    AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21

    Recall: Z-0572-2010 · Initiated October 27, 2009

    Recall

    Recall Number
    Z-0572-2010
    Event Number
    53709
    Firm
    Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
    FEI Number
    3003197096
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2009
    Posted
    December 28, 2009
    Terminated
    November 24, 2010
    Address
    120 Vintage Dr NE, Huntsville, AL, 35811-8216

    Description

    AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21

    Reason

    Needles are becoming dislodged from the barrels

    Action

    The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.

    Distribution

    Nationwide

    Quantity

    480,045 cartons of 100