22 Apr 2009
Vickmans Laboratories Ltd. (Vickmans), a local drugs manufacturer, was ordered to suspend operation to facilitate the investigation into a suspected case of fungal contamination involving two batches of frusemide 40 mg tablets (trade name Diurex with registration no. HK-51628) manufactured by the company, a spokesman for the Department of Health said today (April 22).
The company has also been asked to conduct a consumer level recall.
The spokesman said the investigation was conducted upon receiving a report from the Hospital Authority yesterday that black dots were found on Diurex 40 mg tablets supplied to Queen Mary Hospital and Kennedy Town Jockey Club Clinic.
Preliminary investigation found growth of aspergillus species (a kind of fungus) on the tablets. The fungus is commonly found in the environment. It does not usually cause disease in man unless the person's immunity is impaired or there is a very heavy dose of the fungus. Infection through oral route is uncommon.
Frusemide is a prescription drug and is commonly used for decreasing oedema associated with heart, liver, or kidney disease and also for the treatment of high blood pressure.
Initial enquiries revealed that the affected batches of the drug, involving a total of 800 bottles each containing 1000 tablets, were manufactured in January this year. The batch numbers are 81539 and 81540.
It was reported that 790 bottles had been delivered to public and private hospitals, pharmacies and private doctors between February and April. The remaining 10 bottles were retained by the manufacturer.
Staff of DH's Pharmaceutical Service visited Vickmans last night to inspect the production lines, checked the production records and took away samples of the affected product for further investigations. Samples of the product were also taken from HA for microbial testing.
Black spots were also detected in parts of the product delivered to other public hospitals. Laboratory test results are expected to be available tomorrow.
DH has informed doctors, hospitals and pharmacists and pharmacies of the incident and asked them to stop dispensing Diurex.
Patients should follow HA's advice on drug replacement or consult their doctors if they use private medical service.
A hotline 2125 1122 has been jointly set up by DH and HA for public enquiries. The hotline will operate up to 10 pm today and from 9 am to 6 pm starting tomorrow.
Vickmans has also set up a hotline 2596 1835 for public enquiries.