The Department of Health (DH) today (November 28) endorsed the voluntary recall of one batch (batch number: X012FA-1) of a registered pharmaceutical product, Eye Mo 36 Eye Drops 0.05% (registration number: HK-16622), from consumers by the licensed drug wholesaler, GlaxoSmithKline Limited (GSK), in view of a quality defect - the presence of fine crystals on the bottle.
The company notified the DH that it found the defect when investigating a consumer's enquiry about fine crystals found around the nozzle area of the product. GSK came to confirm the crystals as boric acid deposits, with the acid being an excipient used as a pH buffering agent in the product.
"GSK postulates that the crystal formation might be due to improper temperature or pressure encountered during air shipment of the particular batch. It was the only one dispatched by air, with all others having been sent in by sea," a DH spokesman said.
The wholesaler stressed that it is recalling the batch voluntarily on a precautionary basis.
The spokesman stated that Eye Mo 36, manufactured in Indonesia by PT Sterling Products Indonesia, is an over-the-counter medicine for soothing eye redness and irritation.
According to GSK, it has imported around 31 500 bottles of the affected batch into Hong Kong for supply to local pharmacies as well as medicine companies, with some also re-exported to Macao.
The spokesman said, "So far, no adverse report has been received, but the DH will continue with the investigation while monitoring the recall."
It is noted that GSK has set up a hotline on 3189 8765 to answer related enquiries.
"Members of the public should stop using the affected product immediately. If they are unsure or feel unwell, they should consult their health-care providers as soon as possible," the spokesman said.
"Here, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance Cap. 132, selling any drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is $10,000 and three months' imprisonment."
He added, "On completion of our investigation, we will consult the Department of Justice for advice regarding prosecution."
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201111/28/P201111280357.htm )