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The Department of Health (DH) today (September 2) instructed a licensed drug importer, Global Medical Solutions Hong Kong Ltd (GMS), to recall two batches (Lot no: 0200U and 0200U1) of Neurolite for Inj with Buffer Vial (Registration no: HK-43086) from users as the drug's US manufacturer, Ben Venue Laboratories Inc (BV) has 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 (FDA) 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.
"In fact, BV is simultaneously recalling another radiopharmaceutical called Cardiolite in the US. However, there is no information in hand to show that Hong Kong has ever imported the affected batch," the spokesman clarified.
"On the other hand, 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," the spokesman elaborated.
GMS has set up a hotline (Tel: 2562 9398) to answer related enquiries.
While DH has not received any adverse incident notification in connection, to follow-up on the FDA's alert, DH immediately communicates with the hospitals, including issuing letters, to inform healthcare providers of the international recall, the reason behind and also urges them to stop using the affected batches. They are also reminded to report on any related side effect.
"Clients who have been given the affected batches will be approached by their attending healthcare providers. Nonetheless, whenever they are in doubt or feel unwell, they can consult their attending providers in turn," the spokesman advised.
Ends/Friday, September 2, 2011
Issued at HKT 20:00
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