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
CHP announces one new confirmed melioidosis infection case
The Centre for Health Protection (CHP) of the Department of Health today (October 18) said that one new confirmed melioidosis infection case had been recorded from October 10 to 17.
The case involves a 59-year-old female with underlying illness who lives in Sham Shui Po. She developed a fever and abdominal pain on October 5 and was admitted to Caritas Medical Centre on October 7. She is in stable condition. Her clinical sample was confirmed positive for Burkholderia pseudomallei upon testing.
The CHP is investigating the infection source of the case. Epidemiological investigations are ongoing. So far, 19 melioidosis infection cases have been recorded in Hong Kong this year. In 2023, 17 melioidosis infection cases were recorded.
A spokesman for the CHP reiterated that person-to-person transmission and animal-to-human transmission are rare, but melioidosis bacteria can survive in the local environment. Melioidosis is an endemic disease in Hong Kong and melioidosis cases have been recorded in Hong Kong each year. According to literature, infection cases are more common after typhoons or storms. The bacterium Burkholderia pseudomallei of melioidosis in soil and muddy water may become exposed to the ground after typhoons or storms, and the bacteria could spread more easily with strong winds or storms. As such, the number of melioidosis cases may increase.
The CHP reminded members of the public that melioidosis can be spread by contaminated soil and water during and after typhoons and storms. Where practicable, people should stay indoors during typhoons and storms, avoid travelling to areas with potential flooding, and do not wade in or have contact with muddy water and soil. In addition, high-risk individuals should avoid paths near stormwater drains where aerosols may be generated from contaminated water.
Members of the public should also take the following preventive measures against infection:
Avoid contact with contaminated soil;
Wear appropriate protective clothing or footwear when participating in activities with possible contact with soil or water, e.g. using gloves and wearing boots. High-risk individuals may also consider wearing a surgical mask;
Wash or shower after exposure to contaminated water or soil;
Always clean any wounds as soon as possible and cover any cuts or grazes with waterproof dressings;
Wash hands with liquid soap and water after handling soil or gardening;
Observe food hygiene and avoid drinking raw water; and
Travellers can contract the disease through outdoor water sports. Risk of infection can be minimised by avoiding exposure to water sources (such as rivers, ponds or lakes) that might be contaminated.
The CHP appealed to members of the public to seek medical advice if they develop symptoms, in particular people with diabetes or other immunocompromised conditions, in order to receive an appropriate medical diagnosis and treatment. For more information on melioidosis, please visit the website of the CHP atwww.chp.gov.hk/en/healthtopics/content/24/101110.html.
