Reported Oct 19, 2016 · Terminated
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a…
Biocompatibles U.K., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocompatibles U.K., Ltd. · Bortoli House · Farnham, N/A · N/A
Is this the product you have?
- TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
- Lot codes and dates
- Lot 1599211
- Expiry Date18SEP2015 (12 days after calibration)
- Amount recalled
- 64 doses
Where it was sold
Why it was recalled
One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq.
This product could cause temporary or reversible health problems — stop using it.
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