Recall of Panadol children tablets (September 01, 2010)
The Department of Health
(DH) today (August 31) endorsed a recall made by GlaxoSmithKline
Ltd. (GSK), a licensed drug wholesaler, of one batch of Panadol for
Children Tablet Chewable 120mg (Registration No.: HK-31209, Batch
no.: XPH026) from the market due to a mismatch of dosage
instructions between the products's package insert and the
carton.
The recall was initiated after GSK found
that the package insert of the concerned batch carried currently
registered dosage instructions based on a child's age while the
carton provided new dosage instructions based on a child's weight.
Although the new dosage instructions have received DH's
approval-in-principle, it may only be used on the condition that
the package insert be changed to the new dosage instruction format
and its commencement date be agreed by DH.
A DH spokesman explained that the old and
new dosage instructions are considered appropriate but the new
instructions are more refined, taking into account the child's
actual body weight instead of just his/ her age.
Around 4,000 packs of the concerned batch
have been sold to about 1,000 retailers in Hong Kong.
The spokesman said that although there is
neither safety nor efficacy concern, GSK nevertheless opted for
voluntary recall so as to avoid confusion. On assessment, the DH
endorsed GSK's decision and will closely monitor the exercise and
the development.
GSK has set up a hotline, 3189 8765, for
public enquiries.
The DH spokesman urged healthcare
professionals and retailers to stop supplying the product to their
clients. "People who have used the product should consult
healthcare professionals if in doubt," he said.
(Reprinted from HKSAR Government web
page
http://www.info.gov.hk/gia/general/201008/31/P201008310266.htm
)
