Press Release
Recall of Eye Mo 36 Eye Drops 0.05%
28 Nov 2011
The Department of Health (DH) today (November 28) endorses the voluntary recall of one batch (batch number: X012FA-1) of a registered pharmaceutical product “Eye Mo 36 Eye Drops 0.05%” (“Eye Mo 36”) (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 DH that it found the defect on investigating into 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 being sent in by sea," a DH spokesman quotes.
The wholesaler stresses that it is recalling the batch voluntarily on a precautionary basis.
The spokesman states 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 comments that “So far, no adverse report has been received, but DH will continue with the investigation while monitoring the recall.”
It is noted that GSK has set up a hotline at 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 healthcare providers as soon as possible," the spokesman emphasizes.
"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 HK$10,000 and three months' imprisonment" the spokesman remarks.
“On completion of our investigation, we will consult the Department of Justice for advice regarding prosecution," the spokesman concludes.
