Health Department Orders Recall of 14 Amitriptyline Tablet Batches Due to Impurity Concerns

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

Hong Kong Customs detects two drug trafficking cases at airport

Hong Kong Customs detected two drug trafficking cases involving baggage concealment at Hong Kong International Airport yesterday (January 11) and seized a total of about 11.5 kilograms of suspected cannabis buds with an estimated market value of about $2.3 million.

The first case involved a 39-year-old non-local male passenger arriving in Hong Kong from Ko Samui, Thailand, yesterday. During customs clearance, about 5.5kg of suspected cannabis buds were found inside his check-in suitcase. The man was subsequently arrested.

The second case involved another non-local male passenger, aged 37, who also arrived in Hong Kong from Ko Samui, Thailand, yesterday. During customs clearance, about 6kg of suspected cannabis buds were found inside his check-in suitcase. He was subsequently arrested.

The arrested persons have each been charged with one count of trafficking in a dangerous drug. The cases will be brought up at the West Kowloon Magistrates' Court tomorrow (January 13).

Customs will continue to step up enforcement against drug trafficking activities through intelligence analysis. The department also reminds members of the public to stay alert and not to participate in drug trafficking activities for monetary return. They must not accept hiring or delegation from another party to carry controlled items into and out of Hong Kong. They are also reminded not to carry unknown items for other people.

Customs will continue to apply a risk assessment approach and focus on selecting passengers from high-risk regions for clearance to combat transnational drug trafficking activities.

Under the Dangerous Drugs Ordinance, trafficking in a dangerous drug is a serious offence. The maximum penalty upon conviction is a fine of $5 million and life imprisonment.

Members of the public may report any suspected drug trafficking activities to Customs' 24-hour hotline 182 8080 or its dedicated crime-reporting email account (crimereport@customs.gov.hk) or online form (eform.cefs.gov.hk/form/ced002).

Hong Kong Customs detects two drug trafficking cases at airport Source: HKSAR Government Press Releases

Hong Kong Customs detects two drug trafficking cases at airport Source: HKSAR Government Press Releases