Hong Kong issues recall over fears drug has cancer-causing impurities inside - South China Morning Post

Health authorities in Hong Kong have recalled a batch of a prescription drug used to treat high blood pressure after it was found to contain an impurity that could cause cancer.

The affected product, Irbesartan HCT Actavis Tablets 150/12.5mg, with Hong Kong registration number HK-63378, has been supplied to local private doctors, pharmacies and a private hospital, according to the medicine wholesaler Actavis Hong Kong.

About 3,600 packs, containing 28 tablets each, were said to be on the market. The drug has the batch number 058818.

Thursday’s recall followed a report by Actavis to the Department of Health that certain batches of the drug’s raw materials were found to contain N-nitrosodiethylamine (NDEA).

NDEA is classed as a probable human carcinogen, a substance that could cause cancer.

In a statement, the department said: “A number of irbesartan-containing products using these raw materials were thus affected. Among the affected products, the [batch of tablets in question] has been imported into, and supplied in, Hong Kong.

“As a precautionary measure, Actavis has voluntarily recalled the affected batch from the market.”

Hong Kong health department issues recall for five heart drugs

According to the department, patients who are taking the drug should not stop, but should seek advice from health care professionals on how to manage their dosage.

Actavis has set up a local hotline, on 3188 4288, to answer questions from the public.

“So far, the department has not received any adverse drug reaction reports related to the affected product,” a department spokesman said. “The department will continue its investigation and will closely monitor the recall.”

Batches of four other Actavis products, used to treat hypertension, were recalled in July this year, also because of a potential cancer-causing impurity detected in the raw material.



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