BEUDAMED
    FDA Recall 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 · Initiated May 20, 2010

    Recall

    Recall Number
    Z-1825-2012
    Event Number
    57878
    Firm
    App Pharmaceuticals Llc
    FEI Number
    3002733956
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    May 20, 2010
    Posted
    June 19, 2012
    Terminated
    June 20, 2012
    Address
    1501 E Woodfield Rd, Suite 300, East Schaumburg, IL, 60173-6052

    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.

    Action

    APP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.

    Distribution

    Nationwide Distribution and Puerto Rico

    Quantity

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