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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

FDA Recall Z-0871-06 · Posted 2006-05-17

Recalling FirmHollister Stier Laboratories LLC
Recall StatusTerminated
Product CodeLDH
Date Initiated2006-04-20
Date Terminated2007-03-03
Product Quantity87,900 vials

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Vials were distributed to clinics, pharmacies and physicians nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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