Batch recall of two products of Apo-Amitriptyline tablets due to presence of impurity
The Department of Health (DH) today (October 18) endorsed a licensed drug wholesaler, Hind Wing Co Ltd, to recall a total of 14 batches of the following two products from the market as a precautionary measure due to the presence of impurity in the products.
Name of product |
Hong Kong registration number |
Batch number |
Apo-Amitriptyline Tablets 10mg |
HK-09273 |
RN6384 |
RR0266 |
RV1644 |
RW8597 |
TA6008 |
TF8585 |
TF8587 |
TF8589 |
Apo-Amitriptyline Tablets 25mg |
HK-09274 |
RM8130 |
RR0781 |
RV1656 |
RW8691 |
TA6062 |
TF8602 |
The DH received notification from Hind Wing that the overseas manufacturer of the products is recalling the above batches of Apo-amitriptyline tablets as they exceed or may exceed the accepted level of an impurity, N-Nitrosonortriptyline (NNORT). NNORT is classified as a probable human carcinogen based on results from laboratory tests. As a precautionary measure, Hind Wing is voluntarily recalling the affected batches of products from the market.
The above products, containing amitriptyline, are prescription medicines used for the treatment of depression. According to Hind Wing, the above batches of products had been imported into Hong Kong. The affected batches of products had been supplied to the DH clinics, pharmacies, private doctors, and private hospitals, and re-exported to Macao.
Hind Wing has set up a hotline (2541 5731) to answer related enquiries.
"So far, the DH has not received any adverse reaction reports in connection with the products. The DH will closely monitor the recall," a spokesman for the DH said.
"Patients who are taking the above products should not stop taking the medicine, but should seek advice from their healthcare professionals as soon as possible for appropriate arrangements," the spokesman added.
Batch recall of two products of Apo-Amitriptyline tablets due to presence of impurity Source: HKSAR Government Press Releases
Batch recall of two products of Apo-Amitriptyline tablets due to presence of impurity Source: HKSAR Government Press Releases
Local pig samples test positive for African Swine Fever virus
The Agriculture, Fisheries and Conservation Department (AFCD) today (January 10) announced that samples taken from a licensed pig farm in Yuen Long had tested positive for the African Swine Fever (ASF) virus.
An AFCD spokesman said, "Eleven pig samples were taken from a licensed pig farm in Wong Nai Tun, Yuen Long today. Upon testing by AFCD staff, at least three samples were found positive for the ASF virus. The AFCD has immediately suspended transportation of any pigs from the farm concerned until further notice according to the contingency plan on ASF. The AFCD is arranging culling of pigs, for the sake of prudence."
He further said, "Positive cases should be seriously and promptly handled as the effect of ASF is very lethal to pigs. If the spread is not contained, a large number of pigs will die and hence seriously impacting pig farmers and the pig rearing industry. AFCD staff immediately notified all local pig farmers of this incident and reminded them to alert the AFCD immediately if abnormal health condition is observed in pigs. In addition, the AFCD is arranging staff to inspect the three pig farms within three kilometres of the index farm and collect pig samples for ASF testing. For the sake of prudence, the AFCD has suspended movements of pigs on those pig farms until further notice. No reports of abnormalities from pig farms outside the three-kilometre zone have been received so far. AFCD staff are continuing close surveillance to detect pigs with abnormalities and if a farm is infected as early as possible. Surveillance of the activities of nearby wild pigs of the index farm would also be stepped up. Besides, the AFCD is maintaining close contact with pig farmers via text message groups, keeping them informed of the latest situation of ASF and ways to prevent the infection of pigs."
The spokesman stressed that ASF is not a zoonotic disease and will not infect humans, hence does not cause any human health and food safety risk. Regardless of whether the pigs are infected with ASF, pork cooked thoroughly is safe for consumption. Members of the public do not need to be concerned. The AFCD has held a seminar for pig farmers on specific preventive measures and biosecurity advice against ASF, with a view to enhancing vigilance of the industry in prevention of ASF. Meanwhile, in order to strengthen the knowledge of local pig farmers of the clinical signs of ASF for early detection and reporting of abnormality of pigs, the AFCD has launched the Guidelines for Reporting Cases of African Swine Fever to assist pig farmers in identifying suspected cases for early reporting and to take appropriate follow-up.
The present case does not affect the operation of local slaughterhouses nor the overall supply of live pigs. Since June 2019, a daily clearance arrangement whereby live pigs will be slaughtered within 24 hours upon admittance has been imposed in Sheung Shui and Tsuen Wan slaughterhouses. Under the arrangement, lairages in different areas of the slaughterhouses will be cleared out and undergo thorough cleaning and disinfection every day to further enhance the biosecurity and minimise the risk of infection among pigs in the slaughterhouses.
The Food and Environmental Hygiene Department and the AFCD will continue to stringently conduct cleaning and disinfection of Mainland live pig transportation vehicles and their counterparts for local pigs at slaughterhouses to minimise the risk of cross-infection of ASF. Mainland live pig vehicles and local ones should be thoroughly cleaned and disinfected every time they leave the Sheung Shui Slaughterhouse (SSSH), and the respective designated positions for their cleaning and disinfection are separated. Manpower and equipment of the SSSH have been strengthened immediately for cleaning and disinfection of the vehicles. In light of these stepped-up measures, the slaughterhouses need not be closed and other pigs need not be culled.
As culling operation takes time, the AFCD will release updated operation information every day later on the departmental web page,www.afcd.gov.hk, for the public.
