Recall of Algikey injection due to quality defect
20 Oct 2011
The Department of Health (DH) today (October 20) instructs a licensed drug wholesaler, Hind Wing Co. Ltd (Hind Wing), to recall a pharmaceutical product called "Algikey Inj 3%" (Registration number: HK-52919) from consumers in view of a quality defect.
A DH spokesman explains that the incident began in August when the Hospital Authority (HA) noted particles in some of its Algikey ampoules in stock. The matter was referred to Hind Wing which asked the product's manufacturer in Spain, Farma Mediterrania (FM), for an investigation in turn.
"Earlier on this month, Hind Wing conveyed to HA that FM reported the cause as isolated, due to carbonisation of the liquid content during sealing of the ampoules," the spokesman quotes.
Algikey Inj 3% is indicated for treatment of moderate to severe pain. A prescription is required and sale must be done under the supervision of a pharmacist.
According to Hind Wing's sales record, 500 boxes have been imported into Hong Kong this January. 477 boxes were supplied to HA and 15 boxes were sold to three private doctors.
"Subsequently, HA resumed use of the injection, only to find particles again in at least three other ampoules. DH was then notified," the spokesman reveals.
"Given that the scale of the defect is more than isolated, FM's manufacturing process is opened to question. Though the defect was reported to be qualitative in nature and no related adverse report has been received thus far, to be prudent for public health protection, recall of the product from consumers is called for," the spokesman comments.
"The incident will also be referred to our Spanish counterpart for their upstream follow up. For the product to resume sale here, the wholesaler must demonstrate to our satisfaction that the cause has been found and remedial measure(s) instituted," the spokesman states.
Healthcare providers in receipt of the above product should stop supplying it further. Hind Wing has set up a hotline at 2566 0178 for related enquiries.
The spokesman also advises members of the public to consult their healthcare providers if they are in doubt or feel unwell after having used the product.
"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. On completion of our investigation, we will consult the Department of Justice for advice regarding prosecution. The matter will also be referred to the Pharmacy and Poisons Board in due course for necessary disciplinary enquiry," the spokesman concludes.