The Department of Health (DH) today (November 28) instructed a licensed drug manufacturer, APT Pharma Limited (APT), to recall a batch (lot number: H00406) of Glupozide 80mg tablets (registration number: HK-48195) in view of a quality defect identified by the DH after following up on a public complaint.
"As DH investigated a user's complaint, we confirmed the finding of a suspected plastic fragment embedded in one of the above tablets," a DH spokesman said.
"So far, this is an isolated detection, with no indication that other batches are affected nor any other report of a related adverse incident," the spokesman continued. The investigation is ongoing.
According to details provided by APT, the tablets were usually manufactured by APT Pharma (China) Co Ltd in Guangdong and then exported to Hong Kong for packaging by APT.
"To be precise, the affected batch was manufactured in Guangdong in June this year. After packaging here, a total of 2 255 boxes of 500 tablets were supplied to various Hospital Authority (HA) hospitals," the spokesman said.
Glupozide 80mg tablets, containing gliclazide, are used for the control of blood glucose in diabetic patients. The tablets require a doctor's prescription and can only be sold in a pharmacy under the supervision of a pharmacist.
DH has already alerted the HA and the Guangdong drug regulatory authority for their necessary follow-up.
APT has also set up a hotline 2341 7878 for public enquiries.
"Here, contravention of the Public Health and Municipal Services Ordinance (Cap 132), selling drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is HK$10,000 and three months' imprisonment. The DH will seek advice from the Department of Justice on completion of the investigation.
"Meanwhile, members of the public who are taking the above medicine should check the tablet, even splitting it for examination if necessary, before use. However, balancing the risks versus benefits, they must not stop using the drug abruptly, but instead ought to seek healthcare professionals' advice if in doubt or feeling unwell," the spokesman said.
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201111/28/P201111280326.htm )