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Terminated

Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

FDA Recall Z-1162-2013 · Posted 2013-04-23

Recalling FirmSirtex Medical Limited
Recall StatusTerminated
Product CodeNAW
Date Initiated2013-02-27
Date Terminated2015-03-30
Product Quantity21 doses

Reason for Recall

Incorrect expiration date

Firm Action

Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.

Official Source

View FDA Recall →

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

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