The Department of Health (DH) today (August 28) endorsed a licensed pharmaceutical manufacturer, The United Laboratories Ltd (TUL), to voluntarily recall one batch (batch number: 20207) of Vitamin C Effervescent Tablets (Blackcurrant flavour) from the overseas market due to a potential quality issue. The product is not a locally registered pharmaceutical product and is not marketed in Hong Kong.
Upon complaints received earlier, the DH immediately conducted site investigations and collected 13 samples of products for laboratory analysis. Results today revealed that all samples complied with pharmacopoeial standards and the manufacturer's specifications. However, in the above batch of Vitamin C Effervescent Tablets (Blackcurrant flavour), the sample was found to contain a trace amount of arsenic, 0.83 milligrams per kilogram (mg/kg). Based on the recommended dosage of the product, the estimated intake of arsenic from the affected batch should pose a very low health risk. Arsenic was not detected in samples from other batches of the product.
"The presence of arsenic indicates that the above batch of the product may have been contaminated. Preliminary investigations show that the contaminant may have been introduced to the product when part of the manufacturer's production equipment broke down in April. As a precautionary measure, TUL is voluntarily recalling the above batch from the market. The product is manufactured for export only and we have already notified the relevant drug regulatory authorities on the issue. So far, no other products were found to have been affected," a spokesman for the DH said.
According to TUL, the affected batch was manufactured in April. About 9 730 bottles (15 tablets per bottle) of the batch have been exported to a market outside Hong Kong in May. In the past five years, TUL has only manufactured products for export and none have been supplied to the local market.
The DH will continue the investigations and closely monitor the recall.
Reprinted from HKSAR Government:
http://www.info.gov.hk/gia/general/201508/28/P201508280565.htm