BEUDAMED
    FDA Recall Terminated

    Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207

    Recall: Z-0871-06 · Initiated April 20, 2006

    Recall

    Recall Number
    Z-0871-06
    Event Number
    35212
    Firm
    Hollister Stier Laboratories LLC
    FEI Number
    3010477
    Product Code
    LDH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2006
    Posted
    May 17, 2006
    Terminated
    March 3, 2007
    Address
    3525 N Regal St, Spokane, WA, 99207-5788

    Description

    Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207

    Reason

    Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.

    Action

    On 4/20/06 the firm sent an overnight letter titled DEVICE RECALL to their customers. The consignees were advised of the problem and were requested return of the vials. The letter also instructs consignees that if they have any remaining product in the vials, to destroy the product.

    Distribution

    Vials were distributed to clinics, pharmacies and physicians nationwide.

    Quantity

    87,900 vials