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Recall of Neurolite for Inj with Buffer Vial

The Department of Health instructed a licensed drug importer, Global Medical Solutions, to recall two batches of Neurolite for Inj with Buffer Vial from users.

 

This comes after the drug's US manufacturer, Ben Venue Laboratories Inc, initiated an international recall after the detection of particulate matter, likely to be stainless steel, in the product.

DH learned of the recall through its ongoing drug surveillance scheme which finds the message in a US Food and Drug Administration enforcement report.  In the US, the drug is named as Neurolite Kit.

"Neurolite for Inj with Buffer Vial is a prescription drug.  GMS imports it to prepare Technetium Tc-99m Bicisate for Injection, a radiopharmaceutical for diagnostic radiology use," a DH spokesman explained.

According to the spokesman, GMS' sales record shows that it imported 80 vials of the product from the US in 2011.  Of these, it used 56 vials to make Technetium Tc-99m Bicisate for Injection which was then supplied to both public and private hospitals.  17 vials were re-exported to Thailand, while GMS still keeps the remaining 7 vials.

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