The Department of Health (DH) today (July 12) instructed two licensed drug wholesalers, namely Swedish Trading Company Ltd. (Swedish Trading) and Luen Cheong Hong Limited (LCH), to conduct a shelf recall for all batches of Sertraline Tablet 50mg (Registration Number: HK-59873),and all batches of Totamol Tablet 50mg (Registration Number: HK-44512) and 100mg (Registration Number: HK-44513) respectively, as these products have not been manufactured in line with Good Manufacturing Practice (GMP) requirements.
Through the DH's drug surveillance system, it is noted today that the United Kingdom's drug regulatory authority, Medicines and Healthcare Products Regulatory Agency (MHRA), has initiated a precautionary recall of various medicines manufactured by Wockhardt Limited (Wockhardt). The recall was due to the identification of manufacturing deficiencies by the MHRA at the manufacturing site in India. According to MHRA, although the affected medicines have not been manufactured in line with GMP requirements, there is no evidence of a risk to patient safety from the products.
In Hong Kong, three pharmaceutical products manufactured by Wockhardt are being marketed in Hong Kong. The DH has contacted MHRA for further information about the incident.
According to the wholesalers, Sertraline Tablet 50mg have been supplied to private doctors and local pharmacies while Totamol Tablet 50mg and 100mg have been supplied to public and private hospitals, DH's clinics, private doctors, local pharmacies, and also exported to Macao.
Sertraline Tablet 50mg is used for the treatment of depression while Totamol Tablets, containing atenolol, are used for the treatment of hypertension. They are both prescription medicines and can only be supplied at pharmacies under the supervision of a registered pharmacist upon doctors' prescription.
So far, DH has not received any adverse reaction report in connection with the products.
Swedish Trading has set up a hotline (6718 8005) to answer public enquiries.
LCH has also set up hotlines (3796 5191, 3796 5192, 3796 5193, 3796 5194 and 3796 5195) to answer related enquiries.
DH will closely monitor the recall.
"Healthcare professionals and pharmacies are advised to stop supplying the products to patients. However, members of the public who are taking the products should not stop taking their medicines as there is no evidence of a risk to patient safety from the products. If in doubt or feeling unwell, they should seek advice from their healthcare providers," a DH spokesperson advised.
Through the DH's drug surveillance system, it is noted today that the United Kingdom's drug regulatory authority, Medicines and Healthcare Products Regulatory Agency (MHRA), has initiated a precautionary recall of various medicines manufactured by Wockhardt Limited (Wockhardt). The recall was due to the identification of manufacturing deficiencies by the MHRA at the manufacturing site in India. According to MHRA, although the affected medicines have not been manufactured in line with GMP requirements, there is no evidence of a risk to patient safety from the products.
In Hong Kong, three pharmaceutical products manufactured by Wockhardt are being marketed in Hong Kong. The DH has contacted MHRA for further information about the incident.
According to the wholesalers, Sertraline Tablet 50mg have been supplied to private doctors and local pharmacies while Totamol Tablet 50mg and 100mg have been supplied to public and private hospitals, DH's clinics, private doctors, local pharmacies, and also exported to Macao.
Sertraline Tablet 50mg is used for the treatment of depression while Totamol Tablets, containing atenolol, are used for the treatment of hypertension. They are both prescription medicines and can only be supplied at pharmacies under the supervision of a registered pharmacist upon doctors' prescription.
So far, DH has not received any adverse reaction report in connection with the products.
Swedish Trading has set up a hotline (6718 8005) to answer public enquiries.
LCH has also set up hotlines (3796 5191, 3796 5192, 3796 5193, 3796 5194 and 3796 5195) to answer related enquiries.
DH will closely monitor the recall.
"Healthcare professionals and pharmacies are advised to stop supplying the products to patients. However, members of the public who are taking the products should not stop taking their medicines as there is no evidence of a risk to patient safety from the products. If in doubt or feeling unwell, they should seek advice from their healthcare providers," a DH spokesperson advised.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201307/12/P201307120636.htm