BEUDAMED
    FDA Enforcement Class II Terminated

    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

    Recall: Z-1825-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1825-2012
    Event ID
    57878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    App Pharmaceuticals Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    May 20, 2010
    Classification Date
    June 19, 2012
    Termination Date
    June 20, 2012
    Address
    1501 E Woodfield Rd, Suite 300 East, Schaumburg, IL, 60173-6052, United States

    Description

    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

    Reason

    CGMP Deviations: Incomplete documentation associated with test results.

    Code Info

    Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)

    Distribution

    Nationwide Distribution and Puerto Rico

    Quantity

    Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials